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510(k) K133358

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT by Nidek Co., Ltd. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2014
Date Received
October 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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