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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
Applicant Contact EILEEN T SCHWEIGHARDT
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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