FDA 510(k) Application Details - K993860

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

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510(K) Number K993860
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
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Contact ROGER L RICHINS
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 11/15/1999
Decision Date 12/03/1999
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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