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FDA 510(k) Application Details - K022117
Device Classification Name
Trocar
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1390
More FDA Info for this Regulation Number
Classification Product Code
DRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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