The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Mitraflex(tm) Wound Dressing.
| Device ID | K873277 |
| 510k Number | K873277 |
| Device Name: | MITRAFLEX(TM) WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MATRIX MEDICA, INC. 4050 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Kerry L Graf |
| Correspondent | Kerry L Graf MATRIX MEDICA, INC. 4050 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-17 |
| Decision Date | 1987-09-17 |