FDA 510(k) Application Details - K955611

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K955611
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	GATORZ L.L.C. 5384 LINDA VISTA RD. #104 SAN DIEGO, CA 92110 US Other 510(k) Applications for this Company
Contact	KEN WILSON 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	12/08/1995
Decision Date	01/03/1996
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