FDA 510(k) Application Details - K040786

Device Classification Name Wire, Guide, Catheter

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510(K) Number K040786
Device Name Wire, Guide, Catheter
Applicant NEO METRICS, INC.
14800 28TH AVENUE NORTH
SUITE 150
PLYMOUTH, MN 55447 US
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Contact GENE CHAMPEAU
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 03/29/2004
Decision Date 04/19/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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