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FDA 510(k) Application Details - K014068
Device Classification Name
Controller, Foot, Handpiece And Cord
More FDA Info for this Device
510(K) Number
K014068
Device Name
Controller, Foot, Handpiece And Cord
Applicant
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLAZER-STRASSE
BUERMOOS 5111 AT
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Contact
RALF BENDA
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2001
Decision Date
05/03/2002
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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