FDA 510(k) Application Details - K010779

Device Classification Name	Pneumoperitoneum Needle   More FDA Info for this Device
510(K) Number	K010779
Device Name	Pneumoperitoneum Needle
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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2001
Decision Date	04/10/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review