FDA 510(k) Application Details - K180195

Device Classification Name	Unit, Cryophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K180195
Device Name	Unit, Cryophthalmic, Ac-Powered
Applicant	Phakos 62 Rue KlΘber Montreuil 93100 FR Other 510(k) Applications for this Company
Contact	Olivier Aumaitre 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	01/24/2018
Decision Date	03/16/2018
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