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510(k) K111531

RHA2020 by Annidis Health Systems Corp. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2011
Date Received
June 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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