FDA 510(k) Application Details - K971992

Device Classification Name	Clamp, Penile   More FDA Info for this Device
510(K) Number	K971992
Device Name	Clamp, Penile
Applicant	UROMED CORP. 64 A ST. NEEDHAM, MA 02194 US Other 510(k) Applications for this Company
Contact	NANCY MACDONALD 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	05/29/1997
Decision Date	08/01/1997
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