FDA 510(k) Application Details - K974414

Device Classification Name	Sunglasses (Non-Prescription Including Photosensitive)   More FDA Info for this Device
510(K) Number	K974414
Device Name	Sunglasses (Non-Prescription Including Photosensitive)
Applicant	MORNING CALM CORP. 1106 SEONG AN OFFICETEL 87-36, DURYU-2DONG,DALSEO-GU DAEGU KR Other 510(k) Applications for this Company
Contact	ALEXANDER B KIM 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	11/24/1997
Decision Date	12/08/1997
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