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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K981155
Device Name FLAPMAKER DISPOSABLE MICROKERATOME
Applicant
HAWKEN INDUSTRIES
26650 RENAISSANCE PKWY., STE.3
CLEVELAND,  OH  44128
Applicant Contact GE0RGE MYERS
Correspondent
HAWKEN INDUSTRIES
26650 RENAISSANCE PKWY., STE.3
CLEVELAND,  OH  44128
Correspondent Contact GE0RGE MYERS
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/31/1998
Decision Date 08/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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