FDA 510(k) Application Details - K962087

Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

  More FDA Info for this Device
510(K) Number K962087
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant MEDICON, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
Other 510(k) Applications for this Company
Contact HOWARD M HOLSTEIN, ESQ.
Other 510(k) Applications for this Contact
Regulation Number 878.4820

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

  More FDA Info for this Product Code
Date Received 05/28/1996
Decision Date 04/23/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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