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FDA 510(k) Application Details - K171362
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K171362
Device Name
Syringe, Piston
Applicant
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan, UT 84095 US
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Contact
Cory Marsh
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Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
05/09/2017
Decision Date
08/07/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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