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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 K123213
FOIA Releasable 510(k) K123213
Device Name BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
MC237
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact JOHN ROBERTS
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
MC237
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact JOHN ROBERTS
Regulation Number880.5440
Classification Product Code
ONB  
Date Received10/15/2012
Decision Date 01/09/2013
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
Recalls CDRH Recalls
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