FDA 510(k) Application Details - K963890

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K963890
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	ITALIAN EYEWEAR, INC. 7220 NW 36TH ST. SUITE NO. 429 MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	ALESSANDRO RESTIVO 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	09/26/1996
Decision Date	11/19/1996
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