The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Tyco Healthcar with the FDA for Copa Amd.
| Device ID | K082296 |
| 510k Number | K082296 |
| Device Name: | COPA AMD |
| Classification | Dressing, Wound, Drug |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | James Welsh |
| Correspondent | James Welsh COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR 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 | 2008-08-12 |
| Decision Date | 2009-02-26 |
| Summary: | summary |