FDA 510(k) Application Details - K994111

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

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510(K) Number K994111
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant B. BRAUN/MCGAW
901 MARCON BLVD.
ALLENTOWN, PA 18103-9341 US
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Contact VALERIE LEWIS
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 12/06/1999
Decision Date 01/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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