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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 Dr.
Mc 372
Franklin Lakes,  NJ  07417
Applicant Contact EILEEN HILLER
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
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
Predetermined Change
Control Plan Authorized		 No
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