Data / Medical devices / United States / Amcor Flexibles, Commerce
Amcor Flexibles, Commerce: FDA-registered device maker in Commerce, CA, United States, 1 510(k) clearance
Amcor Flexibles, Commerce is registered with the FDA (registration 2023811) in Commerce, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 1983. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2023811
- Address
- 5416 Union Pacific Ave, Commerce, CA, United States, 90022
- Owner or operator
- Amcor Flexibles, Commerce (9921036)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Contract manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 2, 1983 | K831425 | MDT CHEMITEST SEE-THRU BAG | FRG | Substantially Equivalent | Kenpak Converters, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Wrap, Sterilization
- All makers of Mesh, Surgical
Updated June 2, 1983. 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.