FDA 510(k) Application Details - K160859

Device Classification Name	Lens, Contact (Orthokeratology)   More FDA Info for this Device
510(K) Number	K160859
Device Name	Lens, Contact (Orthokeratology)
Applicant	CONTAMAC LTD. CARLTON HOUSE SHIRE HILL SAFFRON WALDEN cb11 3au GB Other 510(k) Applications for this Company
Contact	ROB MCGREGOR Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	MUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2016
Decision Date	07/13/2016
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