Data / Medical devices / United States / Atlanta Healthcare Services

Atlanta Healthcare Services: FDA-registered device maker in Lawrenceville, GA, United States, 4 510(k) clearances

Name: Atlanta Healthcare Services FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Atlanta Healthcare Services is registered with the FDA (registration 3005391805) in Lawrenceville, GA, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 7, 1994. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005391805
Address: 414 S Perry St, Lawrenceville, GA, United States, 30046
Owner or operator: ATLANTA HEALTHCARE SERVICES (9077141)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 6, 2005
Registered through: 2027
Brand names listed: GUARDIAN, OcuDrape, OcuPak, OcuPak OcuDrape, Ophthalmic Wipe, Private Label

Devices it lists

Device	Product code	Class	Role	Source
Drape, Patient, Ophthalmic	HMT	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Drape, Surgical, Ent	ERY	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
General Surgery Tray	LRO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Repackager or relabeler, Specification developer	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 7, 1994	K931562	GUARDIAN SURGEON'S GOWNS	FYA	Substantially Equivalent	Atkins Healthcare Services	accessdata.fda.gov
July 15, 1994	K942642	SURGI-WIPE	HOZ	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.	accessdata.fda.gov
February 13, 1986	K854613	SURGICAL DRAPES, OPHTHALMIN	HMT	Substantially Equivalent	Charles Atkins & Co.	accessdata.fda.gov
November 17, 1985	K853759	CUSTOM PROCEDURAL TRAY PROCEDURAL KIT		Unknown	Charles Atkins & Co.	accessdata.fda.gov

Compare with other makers

Updated October 7, 1994. 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.