FDA 510(k) Application Details - K062414

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

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510(K) Number K062414
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant RITA MEDICAL SYSTEMS, INC.
ONE HORIZON WAY
MANCHESTER, GA 31816 US
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Contact DAVID SMITH
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 08/17/2006
Decision Date 02/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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