The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Surgical Cutter.
| Device ID | K955168 |
| 510k Number | K955168 |
| Device Name: | SURGICAL CUTTER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-01-22 |