FDA 510(k) Application Details - K972850

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K972850
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	INDOPTICA, S.A. 1275 BEECHNUT PLACE, SUITE A POMONA, CA 91766 US Other 510(k) Applications for this Company
Contact	JOHN R HONEY 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	08/01/1997
Decision Date	09/17/1997
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