FDA 510(k) Application Details - K150800

Device Classification Name Needle, Catheter

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510(K) Number K150800
Device Name Needle, Catheter
Applicant B. Braun Medical Inc
901 Marcon Blvd
Allentown, PA 18109 US
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Contact Nancy Skocypec
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Regulation Number 878.4200

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Classification Product Code GCB
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Date Received 03/26/2015
Decision Date 11/12/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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