The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Seamguard Bioabsorbable Staple Line Reinforcement Material.
| Device ID | K043056 |
| 510k Number | K043056 |
| Device Name: | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | Brandon Hanson |
| Correspondent | Brandon Hanson 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132627127 | K043056 | 000 |
| 00733132620029 | K043056 | 000 |
| H3731BSGTRI45B39 | K043056 | 000 |
| 00733132600885 | K043056 | 000 |
| 00733132600878 | K043056 | 000 |
| 00733132600861 | K043056 | 000 |
| 00733132600854 | K043056 | 000 |
| 00733132600847 | K043056 | 000 |
| 00733132600830 | K043056 | 000 |
| H3731BSGETS453 | K043056 | 000 |
| H3731BSGEC60A30 | K043056 | 000 |
| 00733132600809 | K043056 | 000 |
| H3731BSGEC453 | K043056 | 000 |
| H3731BSGTRI60B36 | K043056 | 000 |
| 00733132620043 | K043056 | 000 |
| 00733132600328 | K043056 | 000 |
| 00733132627110 | K043056 | 000 |
| 00733132627103 | K043056 | 000 |
| 00733132627097 | K043056 | 000 |
| 00733132627080 | K043056 | 000 |
| 00733132627073 | K043056 | 000 |
| 00733132627066 | K043056 | 000 |
| 00733132627059 | K043056 | 000 |
| 00733132627042 | K043056 | 000 |
| 00733132627035 | K043056 | 000 |
| 00733132627028 | K043056 | 000 |
| 00733132600342 | K043056 | 000 |
| 00733132600335 | K043056 | 000 |
| 00733132627189 | K043056 | 000 |