The following data is part of a premarket notification filed by Comeg Endoscopy with the FDA for Comeg Endoscopy Resectoscope Accessories.
| Device ID | K970764 |
| 510k Number | K970764 |
| Device Name: | COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | COMEG ENDOSCOPY 13790 EAST RICE PLACE Aurora, CO 80015 |
| Contact | Kaelyn Hadley |
| Correspondent | Kaelyn Hadley COMEG ENDOSCOPY 13790 EAST RICE PLACE Aurora, CO 80015 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-04-22 |
| Summary: | summary |