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510(k) K002044

MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT by Magna Fortis Corporation — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2000
Date Received
July 5, 2000
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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