The following data is part of a premarket notification filed by Deep Blue Medical Advances, Inc. with the FDA for T-line Hernia Mesh.
| Device ID | K193144 |
| 510k Number | K193144 |
| Device Name: | T-Line Hernia Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Deep Blue Medical Advances, Inc. 701 W Main Street, Suite 410 Durham, NC 27701 |
| Contact | William Perry |
| Correspondent | Nancy Lince Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, CA 95483 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002394061 | K193144 | 000 |
| 00850002394054 | K193144 | 000 |
| 00850002394047 | K193144 | 000 |
| 00850002394030 | K193144 | 000 |
| 00850002394023 | K193144 | 000 |
| 00850002394016 | K193144 | 000 |
| 00850002394009 | K193144 | 000 |