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FDA 510(k) Application Details - K123609
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K123609
Device Name
Wire, Guide, Catheter
Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 South Velasco St
Angleton, TX 77515 US
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Contact
STEPHANIE ERSKINE
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/2012
Decision Date
01/16/2013
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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