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FDA 510(k) Application Details - K151194
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K151194
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
SOADCO, S.L.
AVGDA FITER I ROSELL., 4 BIS-LOCAL 2
ESCALDES-ENGORDANY AD-700 AD
Other 510(k) Applications for this Company
Contact
Maria Mitjaneta
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/04/2015
Decision Date
01/29/2016
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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