FDA 510(k) Application Details - K972860

Device Classification Name	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment   More FDA Info for this Device
510(K) Number	K972860
Device Name	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Applicant	BIOLECTRON, INC. 200 HOLT ST. HACKENSACK, NJ 07601 US Other 510(k) Applications for this Company
Contact	RICHARD S DUGOT Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	HSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1997
Decision Date	10/31/1997
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