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FDA 510(k) Application Details - K152463
Device Classification Name
Prosthesis, Chin, Internal
More FDA Info for this Device
510(K) Number
K152463
Device Name
Prosthesis, Chin, Internal
Applicant
PORIFEROUS LLC
535 PINE ROAD, SUITE 206
NEWNAN, GA 30263-7640 US
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Contact
JERRI L. MANN
Other 510(k) Applications for this Contact
Regulation Number
878.3550
More FDA Info for this Regulation Number
Classification Product Code
FWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2015
Decision Date
01/20/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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