FDA 510(k) Application Details - K953133

Device Classification Name Catheter, Continuous Flush

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510(K) Number K953133
Device Name Catheter, Continuous Flush
Applicant SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact SHARON D KVISTAD
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 07/06/1995
Decision Date 02/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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