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510(k) K072259

OPHTHALMOSCOPE F-10 by Nidek Co., Ltd. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2008
Date Received
August 14, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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