FDA 510(k) Application Details - K122088

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K122088
Device Name Device, Percutaneous Retrieval
Applicant MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact MARK MULLANEY
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 07/16/2012
Decision Date 12/05/2012
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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