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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 K020482
Device Name KERATOME BLADE 200200 & 600600
Applicant
MICROSPECIALTIES, INC.
264 QUARRY RD.
MILFORD,  CT  06460
Applicant Contact CHARLES VASSALLO
Correspondent
MICROSPECIALTIES, INC.
264 QUARRY RD.
MILFORD,  CT  06460
Correspondent Contact CHARLES VASSALLO
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/13/2002
Decision Date 12/16/2002
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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