The following data is part of a premarket notification filed by Omnisonics Medical Technologies with the FDA for Omnisonics Ultrasonic Probes.
| Device ID | K993628 |
| 510k Number | K993628 |
| Device Name: | OMNISONICS ULTRASONIC PROBES |
| Classification | Instrument, Ultrasonic Surgical |
| 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 | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-27 |
| Decision Date | 1999-12-15 |
| Summary: | summary |