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510(k) K974598

MICROKERATOME OR THE MATE by Howard Instruments, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1998
Date Received
December 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

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  • K972727 — CBALK-1000 BLADE (October 10, 1997)

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  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
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