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FDA 510(k) Application Details - K161021
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K161021
Device Name
Marker, Radiographic, Implantable
Applicant
DEVICOR MEDICAL PRODUCTS, INC.
300 E-BUSINESS WAY,
FIFTH FLOOR
Cincinnati, OH 45241 US
Other 510(k) Applications for this Company
Contact
SHAWNA ROSE
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
04/12/2016
Decision Date
05/05/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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