FDA 510(k) Application Details - K972717

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K972717
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	RUFF HOUSE, INC. 136 COMMONWEALTH RD. ROCHESTER, NY 14618 US Other 510(k) Applications for this Company
Contact	THOMAS C RUFF 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	07/21/1997
Decision Date	08/25/1997
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