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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 Rd.
Milford,  CT  06460
Applicant Contact LEIGH S AYRES
Correspondent
Micro Specialties, Inc.
264 Quarry Rd.
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
Predetermined Change
Control Plan Authorized		 No
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