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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(k) Number K130197
Device Name BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Applicant Contact JOHN ROBERTS
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Mc 237
Franklin Lakes,  NJ  07417
Correspondent Contact JOHN ROBERTS
Regulation Number880.5440
Classification Product Code
ONB  
Date Received01/28/2013
Decision Date 02/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
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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