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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, sharps
510(k) Number K112774
Device Name BD RECYKLEEN SHARPS COLLECTORS
Applicant
Becton, Dickinson and Company
1 BECTON DRIVE MC 372
FRANKLIN LAKES,  NJ  07417
Applicant Contact EILEEN HILLER
Correspondent
Becton, Dickinson and Company
1 BECTON DRIVE MC 372
FRANKLIN LAKES,  NJ  07417
Correspondent Contact EILEEN HILLER
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/23/2011
Decision Date 03/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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