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510(k) K973950

RETINAL CUBE by Applied Spectral Imaging , Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1997
Date Received
October 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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