FDA 510(k) Application Details - K960289

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K960289
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	JAMES KOREA CO., LTD. P.O. BOX 162021 MIAMI, FL 33116-2021 US Other 510(k) Applications for this Company
Contact	J J HERNANDEZ 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	01/22/1996
Decision Date	02/16/1996
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