The following data is part of a premarket notification filed by Tyco Healthcare Group, Lp with the FDA for Copa Amd Antimicrobial Wound Dressing.
| Device ID | K071371 |
| 510k Number | K071371 |
| Device Name: | COPA AMD ANTIMICROBIAL WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | TYCO HEALTHCARE GROUP, LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | James Walsh |
| Correspondent | James Walsh TYCO HEALTHCARE GROUP, LP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| 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 | 2007-05-16 |
| Decision Date | 2007-11-19 |
| Summary: | summary |