FDA 510(k) Application Details - K121030

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K121030
Device Name	Case, Contact Lens
Applicant	SACKS HOLDINGS, INC. P.O. BOX 676211 RANCHO SANTA FE, CA 92067 US Other 510(k) Applications for this Company
Contact	DEVIN CHODOROW Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2012
Decision Date	07/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review