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FDA 510(k) Application Details - K171189
Device Classification Name
Agent, Polishing, Abrasive, Oral Cavity
More FDA Info for this Device
510(K) Number
K171189
Device Name
Agent, Polishing, Abrasive, Oral Cavity
Applicant
E.M.S. Electro Medical Systems S.A.
Chemin de la Vuarpilliere 31
Nyon ch-1260 CH
Other 510(k) Applications for this Company
Contact
Suzanne Fassio-Hardy
Other 510(k) Applications for this Contact
Regulation Number
872.6030
More FDA Info for this Regulation Number
Classification Product Code
EJR
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More FDA Info for this Product Code
Date Received
04/24/2017
Decision Date
09/11/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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