The following data is part of a premarket notification filed by Polyremedy, Inc. with the FDA for Poly Fit High Hydrating Antimicrobial Dressings.
| Device ID | K092348 |
| 510k Number | K092348 |
| Device Name: | POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | POLYREMEDY, INC. 24372 MCCLOUD COURT Laguna Niguel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik POLYREMEDY, INC. 24372 MCCLOUD COURT Laguna Niguel, CA 92677 |
| 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 | 2009-08-04 |
| Decision Date | 2010-04-08 |