FDA 510(k) Application Details - K970023

Device Classification Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K970023
Device Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant	MEDNEXT, INC. 5490 DEXTER WAY WEST PALM BEACH, FL 33407 US Other 510(k) Applications for this Company
Contact	THOMAS J MICKEL 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	01/03/1997
Decision Date	02/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review