The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Preclude Acuseal Dura Substitute.
| Device ID | K984534 |
| 510k Number | K984534 |
| Device Name: | PRECLUDE ACUSEAL 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 | 1998-12-21 |
| Decision Date | 1999-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132602001 | K984534 | 000 |
| 00733132601998 | K984534 | 000 |
| 00733132601981 | K984534 | 000 |
| 00733132601974 | K984534 | 000 |
| 00733132601967 | K984534 | 000 |
| 00733132601950 | K984534 | 000 |
| 00733132601943 | K984534 | 000 |