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FDA 510(k) Application Details - K151998
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K151998
Device Name
Marker, Radiographic, Implantable
Applicant
AUGMENIX, INC.
204 SECOND AVENUE, LOWER LEVEL
WALTHAM, MA 02451 US
Other 510(k) Applications for this Company
Contact
NOEL ROLON
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
07/20/2015
Decision Date
08/19/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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