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510(k) K131939

AMICO DH-W35 OPHTHALMOSCOPE SERIES by Amico Diagnostic Incorporated — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2014
Date Received
June 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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