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FDA 510(k) Application Details - K213742
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K213742
Device Name
Unit, Operative Dental
Applicant
Olsen Ind·stria e ComΘrcio S.A.
Av. Ivo Luchi, 68
Palhoτa 88133-510 BR
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Contact
Ana Clßudia Espφndola
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/29/2021
Decision Date
10/19/2022
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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