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510(k) K950091

KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 by Konan Medical, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
January 10, 1995
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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  • K040373 — KERATO ANALYZER (EKA) (March 19, 2004)

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