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510(k) K111493

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI by Nidek Co., Ltd. — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2011
Date Received
May 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

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