FDA 510(k) Application Details - K032690

Device Classification Name Instrument, Ultrasonic Surgical

  More FDA Info for this Device
510(K) Number K032690
Device Name Instrument, Ultrasonic Surgical
Applicant MISONIX, INC.
1938 NEW HIGHWAY
FARMINGDALE, NY 11735 US
Other 510(k) Applications for this Company
Contact RONALD R MANNA
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 09/02/2003
Decision Date 12/09/2003
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