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FDA 510(k) Application Details - K212882
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K212882
Device Name
Marker, Radiographic, Implantable
Applicant
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan, UT 84095 US
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Contact
Sari Stevens
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
NEU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2021
Decision Date
04/08/2022
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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