The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Dualmesh Biomaterial.
| Device ID | K992189 |
| 510k Number | K992189 |
| Device Name: | GORE-TEX DUALMESH BIOMATERIAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | R, Larry Pratt |
| Correspondent | R, Larry Pratt W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-29 |
| Decision Date | 1999-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132601073 | K992189 | 000 |
| 00733132600960 | K992189 | 000 |
| 00733132600977 | K992189 | 000 |
| 00733132600984 | K992189 | 000 |
| 00733132600991 | K992189 | 000 |
| 00733132601004 | K992189 | 000 |
| 00733132601011 | K992189 | 000 |
| 00733132601028 | K992189 | 000 |
| 00733132601035 | K992189 | 000 |
| 00733132601042 | K992189 | 000 |
| 00733132601059 | K992189 | 000 |
| 00733132601066 | K992189 | 000 |
| 00733132600953 | K992189 | 000 |