Data / Medical devices / United States / Westrock Converting, LLC

Westrock Converting, LLC: FDA-registered device maker in Bolingbrook, IL, United States, 8 510(k) clearances

Name: Westrock Converting, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Westrock Converting, LLC is registered with the FDA (registration 3004270595) in Bolingbrook, IL, United States. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 19, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004270595
Address: 365 Crossing Road, Bolingbrook, IL, United States, 60440
Owner or operator: WestRock Converting, LLC (9056422)
Roles: Repackager or relabeler
First device listed: September 8, 2003
Registered through: 2026
Brand names listed: Applicator, Q-Tip, CLEAR CARE PLUS Cleaning and Disinfecting Solution, Clear Care Cleaning & Disinfecting Solution, Manual toothbrush, Mighty Patch Mega Pack, Opti Free Puremoist, Opti-Free Puremoist Rewetting Drops, Opti-Free Replenish and more

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Repackager or relabeler	accessdata.fda.gov
Accessories, Soft Lens Products	LPN	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Case, Contact Lens	LRX	2	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Products, Contact Lens Care, Rigid Gas Permeable	MRC	2	Repackager or relabeler	accessdata.fda.gov
Thermometer, Clinical Color Change	FQZ	1	Repackager or relabeler	accessdata.fda.gov
Thermometer, Clinical Mercury	FLK	2	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Ionic, Battery-Powered	MMD	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 19, 2016	K162597	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	LPN	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
January 26, 2015	K142284	CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE	LPN	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
September 15, 2014	K141018	ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT	JEQ	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
May 10, 2011	K102860	ALCON MULTI-PIRPOSE DISINFECTING SOLUTION	LPN	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
June 5, 2006	K061351	ORAL-B SONIC COMPLETE	JEQ	Substantially Equivalent	Braun GmbH	accessdata.fda.gov
September 14, 2005	K050729	ALCON MULTI-PURPOSE DISINFECTING SOLUTION	LPN	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
May 3, 2004	K040312	TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
September 16, 1999	K984573	OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP	LPN	Substantially Equivalent	Alcon Laboratories	accessdata.fda.gov

Compare with other makers

Updated October 19, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.