FDA 510(k) Application Details - K964561

Device Classification Name	Retractor, Fiberoptic   More FDA Info for this Device
510(K) Number	K964561
Device Name	Retractor, Fiberoptic
Applicant	BIOENTERICS CORP. 1035A CINDY LN. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	KEITH LOWREY Other 510(k) Applications for this Contact
Regulation Number	876.4530   More FDA Info for this Regulation Number
Classification Product Code	FDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/1996
Decision Date	02/11/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review