The following data is part of a premarket notification filed by Hydrofera, Llc. with the FDA for Hydrofera Blue Pu Bacteriostatic Dressing.
| Device ID | K130670 |
| 510k Number | K130670 |
| Device Name: | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Contact | Heather S Somers |
| Correspondent | Heather S Somers HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2014-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854827008004 | K130670 | 000 |
| 00854827008820 | K130670 | 000 |
| 00854827008806 | K130670 | 000 |
| 00854827008783 | K130670 | 000 |
| 00854827008769 | K130670 | 000 |
| 00854827008745 | K130670 | 000 |
| 00854827008721 | K130670 | 000 |
| 00854827008707 | K130670 | 000 |