The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Mesh, Surgical, Polymeric.
| Device ID | K982575 |
| 510k Number | K982575 |
| Device Name: | MESH, SURGICAL, POLYMERIC |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-24 |
| Decision Date | 1998-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521176017 | K982575 | 000 |
| 20884521176000 | K982575 | 000 |
| 20884521101316 | K982575 | 000 |
| 20884521101309 | K982575 | 000 |