FDA 510(k) Application Details - K072552

Device Classification Name Wire, Guide, Catheter

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510(K) Number K072552
Device Name Wire, Guide, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact WILLIAM D JORDAN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 09/10/2007
Decision Date 12/14/2007
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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