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FDA 510(k) Application Details - K160248
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K160248
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Argen Corporation
5855 Oberlin Dr
SAN DIEGO, CA 92121 US
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Contact
Paul Cascone
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
02/01/2016
Decision Date
08/05/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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