FDA 510(k) Application Details - K974040

Device Classification Name	Clamp, Penile   More FDA Info for this Device
510(K) Number	K974040
Device Name	Clamp, Penile
Applicant	TIMM RESEARCH CO. 6541 CITY WEST PKWY. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	DAVID ANDERSON 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	10/24/1997
Decision Date	07/14/1998
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