FDA 510(k) Application Details - K963630

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K963630
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	C.O.L.D.A. S.N.C. VIA ARCANE, 25 VALDOBBIADENE (TV) 31049 IT Other 510(k) Applications for this Company
Contact	GALABRETTO GABRIELLA 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	09/11/1996
Decision Date	10/18/1996
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