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FDA 510(k) Application Details - K140382
Device Classification Name
Prosthesis, Tracheal, Expandable
More FDA Info for this Device
510(K) Number
K140382
Device Name
Prosthesis, Tracheal, Expandable
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact
DAN LINDSAY
Other 510(k) Applications for this Contact
Regulation Number
878.3720
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Classification Product Code
JCT
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More FDA Info for this Product Code
Date Received
02/14/2014
Decision Date
11/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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