FDA 510(k) Application Details - K964505

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K964505
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	I C OPTICS, LTD. 366 FIFTH AVE., SUITE 1003 NEW YORK CITY, NY 10001 US Other 510(k) Applications for this Company
Contact	SANFORD HUTTON Other 510(k) Applications for this Contact
Regulation Number	886.5850   More FDA Info for this Regulation Number
Classification Product Code	HQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1996
Decision Date	01/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review