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510(k) K093495

OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS by American Diagnostic Corp. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2010
Date Received
November 10, 2009
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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