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510(k) K042001

PANORAMIC 200A by Optos Plc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2004
Date Received
July 26, 2004
Clearance Type
Traditional
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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