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FDA 510(k) Application Details - K183503
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K183503
Device Name
Marker, Radiographic, Implantable
Applicant
INRAD Inc.
4375 Donker Court SE
Kentwood, MI 49512 US
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Contact
Steve Field
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
NEU
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More FDA Info for this Product Code
Date Received
12/17/2018
Decision Date
10/17/2019
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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