The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Preclude Dura Substitute.
| Device ID | K953969 |
| 510k Number | K953969 |
| Device Name: | PRECLUDE DURA SUBSTITUTE |
| Classification | Dura Substitute |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | John Nicholson |
| Correspondent | John Nicholson W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132601936 | K953969 | 000 |