FDA 510(k) Application Details - K090680

Device Classification Name Heparin, Vascular Access Flush

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510(K) Number K090680
Device Name Heparin, Vascular Access Flush
Applicant BECTON DICKINSON & CO.
1 BECTON DRIVE MC237
FRANKLIN LAKES, NJ 07417 US
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Contact JOHN ROBERTS
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Regulation Number 880.5200

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Classification Product Code NZW
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Date Received 03/16/2009
Decision Date 06/10/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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