FDA 510(k) Application Details - K974511

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K974511
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	SUN WORLD INTL., INC. 316 ROOSEVELT AVE. FRANKLIN SQUARE, NY 11010 US Other 510(k) Applications for this Company
Contact	LILLIAN YEN 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	12/01/1997
Decision Date	01/12/1998
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