The following data is part of a premarket notification filed by Omnisonics Medical Technologies with the FDA for Omnisonic Endoscopic Deflector.
| Device ID | K993445 |
| 510k Number | K993445 |
| Device Name: | OMNISONIC ENDOSCOPIC DEFLECTOR |
| Classification | Endoscope, Rigid |
| Applicant | OMNISONICS MEDICAL TECHNOLOGIES 7 TIFFANY TRAIL Hopkonton, MA 01748 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro OMNISONICS MEDICAL TECHNOLOGIES 7 TIFFANY TRAIL Hopkonton, MA 01748 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 1999-12-06 |
| Summary: | summary |