FDA 510(k) Application Details - K023253

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K023253
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact PATRICIA D WILSON
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 09/30/2002
Decision Date 05/06/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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