The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Preclude Mvp Dura Substitute.
| Device ID | K021477 |
| 510k Number | K021477 |
| Device Name: | PRECLUDE MVP DURA SUBSTITUTE |
| Classification | Dura Substitute |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2002-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132601493 | K021477 | 000 |
| 00733132601486 | K021477 | 000 |
| 00733132601479 | K021477 | 000 |
| 00733132601462 | K021477 | 000 |
| 00733132601455 | K021477 | 000 |