FDA 510(k) Application Details - K955485

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K955485
Device Name Catheter, Intravascular, Diagnostic
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 870.1200

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Classification Product Code DQO
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Date Received 12/01/1995
Decision Date 02/23/1996
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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