FDA 510(k) Application Details - K954864

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K954864
Device Name	Laparoscope, General & Plastic Surgery
Applicant	ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. KALAMAZOO, MI 49009 US Other 510(k) Applications for this Company
Contact	THOMAS J HOOGEBOOM 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	10/23/1995
Decision Date	02/09/1996
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