FDA 510(k) Application Details - K151194

Device Classification Name Abutment, Implant, Dental, Endosseous

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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
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Contact Maria Mitjaneta
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Regulation Number 872.3630

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Classification Product Code NHA
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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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