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510(k) K141638

PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE by Propper Manufacturing Co., Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2014
Date Received
June 19, 2014
Clearance Type
Abbreviated
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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