FDA 510(k) Application Details - K070003

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

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510(K) Number K070003
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant MEDCOMP
1499 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact JEAN CALLOW
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 01/03/2007
Decision Date 05/15/2007
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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