The following data is part of a premarket notification filed by Polyremedy, Inc. with the FDA for Polyfit Absorbing Antimicrobial Dressings (otc).
| Device ID | K121522 |
| 510k Number | K121522 |
| Device Name: | POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) |
| Classification | Dressing, Wound, Drug |
| Applicant | POLYREMEDY, INC. 49 COASTAL OAK Aliso Viejo, CA 92656 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik POLYREMEDY, INC. 49 COASTAL OAK Aliso Viejo, CA 92656 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-05-23 |
| Decision Date | 2012-06-27 |
| Summary: | summary |