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FDA 510(k) Application Details - K130534
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K130534
Device Name
Unit, Operative Dental
Applicant
DIPLOMAT DENTAL S.R.O.
816 CONGRESS AVENUE, SUITE 1400
AUSTIN, TX 78701 US
Other 510(k) Applications for this Company
Contact
STUART R GOLDMAN
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
03/01/2013
Decision Date
10/30/2013
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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