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FDA 510(k) Application Details - K133776
Device Classification Name
Controller, Foot, Handpiece And Cord
More FDA Info for this Device
510(K) Number
K133776
Device Name
Controller, Foot, Handpiece And Cord
Applicant
A-DEC, INC.
2601 CRESTVIEW AVE.
NEWBERG, OR 97132 US
Other 510(k) Applications for this Company
Contact
BONNIE DUNDAS
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
12/12/2013
Decision Date
05/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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