The following data is part of a premarket notification filed by Omnisonics Medical Technologies with the FDA for Omnisonics Flexible Fiber Optic Endoscope And Coupler.
| Device ID | K991377 |
| 510k Number | K991377 |
| Device Name: | OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OMNISONICS MEDICAL TECHNOLOGIES 14 EQUESTRIAN DR. N. Reading, MA 01864 |
| Contact | Deebie Iampietro |
| Correspondent | Deebie Iampietro OMNISONICS MEDICAL TECHNOLOGIES 14 EQUESTRIAN DR. N. Reading, MA 01864 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-07-12 |
| Summary: | summary |