FDA 510(k) Application Details - K971268

Device Classification Name	Motor, Surgical Instrument, Ac-Powered   More FDA Info for this Device
510(K) Number	K971268
Device Name	Motor, Surgical Instrument, Ac-Powered
Applicant	BIOMEDICAL INTERNATIONAL CORP. 14785 OMICRON, DR. SAN ANTONIO, TX 78245 US Other 510(k) Applications for this Company
Contact	CASEY FOX Other 510(k) Applications for this Contact
Regulation Number	878.4820   More FDA Info for this Regulation Number
Classification Product Code	GEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1997
Decision Date	07/03/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review