The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Bioabsorbable Mesh.
| Device ID | K033671 |
| 510k Number | K033671 |
| Device Name: | GORE BIOABSORBABLE MESH |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | OWT |
| Subsequent Product Code | OWZ |
| Subsequent Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2003-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132606153 | K033671 | 000 |
| 00733132606146 | K033671 | 000 |
| 00733132606139 | K033671 | 000 |
| H373FS20303 | K033671 | 000 |
| 00733132605446 | K033671 | 000 |
| 00733132605439 | K033671 | 000 |
| H373FS091533 | K033671 | 000 |
| H373FS080834 | K033671 | 000 |