The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Spyrofilm Iq Wound Dressing(with Inert Filler).
| Device ID | K932676 |
| 510k Number | K932676 |
| Device Name: | SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER) |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-12-10 |