FDA 510(k) Application Details - K022983

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

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510(K) Number K022983
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
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Contact JOHN C KNORPP
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 09/09/2002
Decision Date 09/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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