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FDA 510(k) Application Details - K162756
Device Classification Name
Unit, Cryophthalmic, Ac-Powered
More FDA Info for this Device
510(K) Number
K162756
Device Name
Unit, Cryophthalmic, Ac-Powered
Applicant
PHAKOS
62 RUE KLEBER
MONTREUIL 93100 FR
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Contact
OLIVER 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
09/30/2016
Decision Date
05/03/2017
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
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