The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Promex Ent Tissue Removal System.
| Device ID | K972865 |
| 510k Number | K972865 |
| Device Name: | PROMEX ENT TISSUE REMOVAL SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| 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 | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1997-09-29 |