The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Mitraflex Cavity Wound Dressing.
| Device ID | K935783 |
| 510k Number | K935783 |
| Device Name: | MITRAFLEX CAVITY WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Contact | Andrew M Reed, Ph.d. |
| Correspondent | Andrew M Reed, Ph.d. POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1994-02-04 |