FDA 510(k) Application Details - K974561

Device Classification Name	Device, Irrigation, Ocular Surgery   More FDA Info for this Device
510(K) Number	K974561
Device Name	Device, Irrigation, Ocular Surgery
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	886.4360   More FDA Info for this Regulation Number
Classification Product Code	KYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1997
Decision Date	02/19/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review