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FDA 510(k) Application Details - K083438
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K083438
Device Name
Cement, Dental
Applicant
VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact
TH. PLAUMANN
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2008
Decision Date
02/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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