FDA 510(k) Application Details - K971853

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K971853
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
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	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1997
Decision Date	08/06/1997
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