FDA 510(k) Application Details - K984355

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K984355
Device Name	Laparoscope, General & Plastic Surgery
Applicant	MITAKA USA, INC. 2337 LUCKY JOHN DR. PARK CITY, UT 84060 US Other 510(k) Applications for this Company
Contact	MAX STURGIS 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	12/07/1998
Decision Date	04/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review