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FDA 510(k) Application Details - K193082
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K193082
Device Name
Catheter, Continuous Flush
Applicant
Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan, UT 84095 US
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Contact
Spriha Pandey
Other 510(k) Applications for this Contact
Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
11/05/2019
Decision Date
08/07/2020
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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