The following data is part of a premarket notification filed by Comeg Endoskopie Gmbh with the FDA for Comeg Optical Stone Crushing Forceps, Comeg Visual Obturators For Urology, Comeg Optical Biopsy Forceps.
| Device ID | K971202 |
| 510k Number | K971202 |
| Device Name: | COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | COMEG ENDOSKOPIE GMBH 13790 E. RICE PLACE Aurora, CO 80015 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy COMEG ENDOSKOPIE GMBH 13790 E. RICE PLACE Aurora, CO 80015 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-01 |
| Decision Date | 1997-05-27 |
| Summary: | summary |