Data / Medical devices / United States / Enviropak LLC
Enviropak LLC: FDA-registered device maker in Peachtree City, GA, United States, 1 510(k) clearance
Enviropak LLC is registered with the FDA (registration 1056276) in Peachtree City, GA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 13, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1056276
- FEI number
- 1000132322
- Address
- 218 Claridge Curv, Peachtree City, GA, United States, 30269
- Owner or operator
- ENVIROPAK LLC (9006377)
- Roles
- Manufacturer
- First device listed
- January 6, 2008
- Registered through
- 2026
- Brand names listed
- EnviroPouch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| July 13, 1993 | K924118 | PROPAK | KCT | Substantially Equivalent | Dental Services, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated July 13, 1993. 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.