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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 K980510
Device Name KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
Applicant
Micro Specialties, Inc.
16 Higgins Dr.
Milford,  CT  06460
Applicant Contact CHARLES VASSALLO
Correspondent
Micro Specialties, Inc.
16 Higgins Dr.
Milford,  CT  06460
Correspondent Contact CHARLES VASSALLO
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/10/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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