FDA 510(k) Application Details - K970882

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K970882
Device Name	Endoilluminator
Applicant	AMERICAN MEDICAL DEVICES, INC. 1100 NORTHSIDE DR. ATLANTA, GA 30318 US Other 510(k) Applications for this Company
Contact	FRANK J TIGHE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/1997
Decision Date	06/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review