FDA 510(k) Application Details - K090512

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

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510(K) Number K090512
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact ANGELA M BRADY
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 02/26/2009
Decision Date 03/27/2009
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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