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FDA 510(k) Application Details - K150800
Device Classification Name
Needle, Catheter
More FDA Info for this Device
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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More FDA Info for this Product Code
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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