FDA 510(k) Application Details - K140488

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K140488
Device Name	Case, Contact Lens
Applicant	MACA PLASTICS, INC. 3455 CROSS ROAD WINCHESTER, OH 45697 US Other 510(k) Applications for this Company
Contact	CORRINA CULBERTSON 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	02/27/2014
Decision Date	09/10/2014
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