FDA 510(k) Application Details - K983561

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K983561
Device Name	Laparoscope, General & Plastic Surgery
Applicant	FUJINON, INC. 399 PARK AVE. NEW YORK, NY 10022-4689 US Other 510(k) Applications for this Company
Contact	GARY A ADLER 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	10/13/1998
Decision Date	12/16/1998
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