FDA 510(k) Application Details - K160591

Device Classification Name	Unit, Cryophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K160591
Device Name	Unit, Cryophthalmic, Ac-Powered
Applicant	DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 ZUIDLAND 3214 VN NL Other 510(k) Applications for this Company
Contact	DANIELLE SLEEGERS Other 510(k) Applications for this Contact
Regulation Number	886.4170   More FDA Info for this Regulation Number
Classification Product Code	HRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2016
Decision Date	01/23/2017
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