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FDA 510(k) Application Details - K062219
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K062219
Device Name
Handpiece, Air-Powered, Dental
Applicant
PRODRIVE SYSTEMS, INC.
6062 ARMSTRONG RD.
SPENCERVILLE, ONTARIO K0E 1X0 CA
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Contact
TIM NASON
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Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2006
Decision Date
08/04/2006
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
Y
Expedited Review
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