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FDA 510(k) Application Details - K040153
Device Classification Name
Controller, Foot, Handpiece And Cord
More FDA Info for this Device
510(K) Number
K040153
Device Name
Controller, Foot, Handpiece And Cord
Applicant
INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER
10575 SW 147TH CIRCLE
DUNNELLON, FL 34432 US
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Contact
JESSE SAINT
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Regulation Number
872.4200
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Classification Product Code
EBW
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More FDA Info for this Product Code
Date Received
01/23/2004
Decision Date
05/21/2004
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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