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Data / Medical devices / United States / Packaging Corporation of America

Packaging Corporation of America: FDA-registered device maker in Hanover, PA, United States, 1 510(k) clearance

Packaging Corporation of America is registered with the FDA (registration 3005858760) in Hanover, PA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 1984. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3005858760
FEI number
3015190887
Address
401 Moulstown Rd, Hanover, PA, United States, 17331
Owner or operator
Packaging Corporation of America (10053781)
Roles
Repackager or relabeler
First device listed
January 11, 2017
Registered through
2026
Brand names listed
Mighty Patch, Simply Saline, Trojan

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, EntKCJ1Repackager or relabeleraccessdata.fda.gov
CondomHIS2Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 29, 1984K841600CASABLANCAHISSubstantially EquivalentArcon Corp.accessdata.fda.gov

Compare with other makers

Updated November 29, 1984. 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.