FDA 510(k) Application Details - K103509

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K103509
Device Name	Laparoscope, General & Plastic Surgery
Applicant	UNIMAX MEDICAL SYSTEMS, INC. NO. 45, MINSHEN RD. DANSHUI TOWN TAIPEI COUNTY 251 TW Other 510(k) Applications for this Company
Contact	MICHAEL LEE 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	11/29/2010
Decision Date	05/19/2011
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