FDA 510(k) Application Details - K022110

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

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510(K) Number K022110
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant KAWASUMI LABORATORIES, INC.
1800 MASSACHUSETTS AVE N.W.
SUITE 200
WASHINGTON, DC 20036 US
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Contact DONALD R STONE
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 06/28/2002
Decision Date 09/12/2002
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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