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510(k) K131719

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS by Medical Devices (Pvt) , Ltd. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2013
Date Received
June 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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