FDA 510(k) Application Details - K955810

Device Classification Name	Clamp, Penile   More FDA Info for this Device
510(K) Number	K955810
Device Name	Clamp, Penile
Applicant	LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 MISSISSAUGA (ONTARIO) L4V 1X1 CA Other 510(k) Applications for this Company
Contact	FRED BUFFA Other 510(k) Applications for this Contact
Regulation Number	876.5160   More FDA Info for this Regulation Number
Classification Product Code	FHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/1995
Decision Date	01/24/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review