FDA 510(k) Application Details - K943145

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K943145
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	THE MONTICELLO GROUP, INC. 101 E. MONTICELLO PKWY. STRAFFORD, MO 65757 US Other 510(k) Applications for this Company
Contact	LORI TYNDALL 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	06/30/1994
Decision Date	04/29/1996
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