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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 K033457
Device Name M2 COMPATIBLE MICROKERATOME BLADE
Applicant
MICRO SPECIALTIES, INC.
264 QUARRY ROAD
MILFORD,  CT  06460
Applicant Contact LEIGH S AYRES
Correspondent
MICRO SPECIALTIES, INC.
264 QUARRY ROAD
MILFORD,  CT  06460
Correspondent Contact LEIGH S AYRES
Regulation Number886.4370
Classification Product Code
HNO  
Date Received10/30/2003
Decision Date 05/25/2004
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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