FDA 510(k) Application Details - K051947

Device Classification Name Instrument, Ultrasonic Surgical

  More FDA Info for this Device
510(K) Number K051947
Device Name Instrument, Ultrasonic Surgical
Applicant RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact KEVIN J O'CONNELL
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code LFL
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/18/2005
Decision Date 08/22/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact