The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Prowick Antimicrobial Postoperative Wound Dressing, Shoulder And Knee, Models Ar-1625, Ar-1626.
| Device ID | K072378 |
| 510k Number | K072378 |
| Device Name: | PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 |
| Classification | Dressing, Wound, Drug |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| 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 | 2007-08-24 |
| Decision Date | 2007-11-09 |
| Summary: | summary |