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510(k) K123316

HEINE OMEGA 500 by Heine Optotechnik GmbH & Co. KG — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2013
Date Received
October 25, 2012
Clearance Type
Abbreviated
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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