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FDA 510(k) Application Details - K151967
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K151967
Device Name
Catheter, Hemodialysis, Implanted
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
Other 510(k) Applications for this Company
Contact
Susan Christensen
Other 510(k) Applications for this Contact
Regulation Number
876.5540
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Classification Product Code
MSD
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More FDA Info for this Product Code
Date Received
07/16/2015
Decision Date
04/04/2016
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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