FDA 510(k) Application Details - K955820

Device Classification Name Introducer, Catheter

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510(K) Number K955820
Device Name Introducer, Catheter
Applicant B. BRAUN MEDICAL, INC.
13000 HWY. 55
PLYMOUTH, MN 55441-3813 US
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Contact BARBARA ATZENHOEFER
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 12/26/1995
Decision Date 03/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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