FDA 510(k) Application Details - K022117

Device Classification Name Trocar

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510(K) Number K022117
Device Name Trocar
Applicant MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact STEPHANIE A ERSKINE
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 07/01/2002
Decision Date 10/11/2002
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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