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FDA 510(k) Application Details - K151373
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K151373
Device Name
Kit, Needle, Biopsy
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
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Contact
Ileana Garcia
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
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More FDA Info for this Product Code
Date Received
05/21/2015
Decision Date
08/07/2015
Decision
SESE - SUBST EQUIV
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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