The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Spyroflex Pigmented Wound Dressing/spyroflex Wound Dressing Tinted.
| Device ID | K964398 |
| 510k Number | K964398 |
| Device Name: | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
| Contact | Julie Chaffee |
| Correspondent | Julie Chaffee POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE 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 | 1996-11-04 |
| Decision Date | 1997-10-24 |
| Summary: | summary |