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510(k) K981155

FLAPMAKER DISPOSABLE MICROKERATOME by Hawken Industries — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1998
Date Received
March 31, 1998
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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