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.
| Device ID | K181940 |
| 510k Number | K181940 |
| Device Name: | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Applicant | W. L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21922 |
| Contact | Michael J. Titus |
| Correspondent | Michael J. Titus W. L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21922 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-19 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132644766 | K181940 | 000 |
| 00733132644759 | K181940 | 000 |