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 |