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510(k) K944616

KERATRON CORNEAL TOPOGRAPHER by Alliance Medical Marketinig — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
September 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

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  • K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (December 30, 1991)