The following data is part of a premarket notification filed by Sentron Medical, Inc. with the FDA for Sis Hernia Repair Device.
| Device ID | K974540 |
| 510k Number | K974540 |
| Device Name: | SIS HERNIA REPAIR DEVICE |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SENTRON MEDICAL, INC. 4445 LAKE FOREST DR. SUITE 600 Cincinnati, OH 45242 |
| Contact | Robert J Morff |
| Correspondent | Robert J Morff SENTRON MEDICAL, INC. 4445 LAKE FOREST DR. SUITE 600 Cincinnati, OH 45242 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-03 |
| Decision Date | 1998-05-20 |
| Summary: | summary |