The following data is part of a premarket notification filed by Sonokinetics, Inc. with the FDA for Sonotome.
| Device ID | K990572 |
| 510k Number | K990572 |
| Device Name: | SONOTOME |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SONOKINETICS, INC. 7 TIFFANY TRAIL Hopkinton, MA |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro SONOKINETICS, INC. 7 TIFFANY TRAIL Hopkinton, MA |
| 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 | 1999-02-23 |
| Decision Date | 1999-05-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SONOTOME 74366281 not registered Dead/Abandoned |
Hood, Larry L. 1993-03-09 |