FDA 510(k) Application Details - K992190

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K992190
Device Name	Laparoscope, General & Plastic Surgery
Applicant	CORE DYNAMICS, INC. 11222 ST. JOHNS IND. PKWY. NORTH JACKSONVILLE, FL 32246-6675 US Other 510(k) Applications for this Company
Contact	THOMAS M MCINTOSH 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	06/29/1999
Decision Date	09/01/1999
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