FDA 510(k) Application Details - K012198

Device Classification Name	Trocar, Gastro-Urology   More FDA Info for this Device
510(K) Number	K012198
Device Name	Trocar, Gastro-Urology
Applicant	GIBBONS SURGICAL CORP. 1112 JENSEN DRIVE, STE.101 VIRGINIA BEACH, VA 23451 US Other 510(k) Applications for this Company
Contact	LISA CRISSON Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	FBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2001
Decision Date	08/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review