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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name keratome, battery-powered
510(k) Number K023092
Device Name BD K-4000 MICROKERATOME SYSTEM
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact EILEEN T SCHWEIGHARDT
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact EILEEN T SCHWEIGHARDT
Regulation Number886.4370
Classification Product Code
HMY  
Date Received09/18/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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