FDA 510(k) Application Details - K972958

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K972958
Device Name	Laparoscope, General & Plastic Surgery
Applicant	LYSONIX, INC. 1170 MARK AVE. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	MICHAEL J SARRASIN 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	08/11/1997
Decision Date	09/19/1997
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