FDA 510(k) Application Details - K000545

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K000545
Device Name	Laparoscope, General & Plastic Surgery
Applicant	APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 LAGUNA HILLS, CA 92653 US Other 510(k) Applications for this Company
Contact	ANIL BHALANI Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2000
Decision Date	05/02/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review