FDA 510(k) Application Details - K962107

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K962107
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	LEONACHI, INC. 5943 BISCAYNE BLVD. MIAMI, FL 33137 US Other 510(k) Applications for this Company
Contact	JORGE UJUETA 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	05/31/1996
Decision Date	06/20/1996
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