FDA 510(k) Application Details - K962572

Device Classification Name Wire, Guide, Catheter

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510(K) Number K962572
Device Name Wire, Guide, Catheter
Applicant SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact CONNIE J DEL TORO
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/01/1996
Decision Date 12/17/1996
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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