The following data is part of a premarket notification filed by Comeg Endoscopy with the FDA for Comeg Endoscopy Grasping Forceps.
| Device ID | K970489 |
| 510k Number | K970489 |
| Device Name: | COMEG ENDOSCOPY GRASPING FORCEPS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | COMEG ENDOSCOPY 13790 EAST RICE PLACE Aurora, CO 80015 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy COMEG ENDOSCOPY 13790 EAST RICE PLACE Aurora, CO 80015 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059082031866 | K970489 | 000 |
| 04059082031859 | K970489 | 000 |
| 04059082026091 | K970489 | 000 |
| 04059082026084 | K970489 | 000 |