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FDA 510(k) Application Details - K012914
Device Classification Name
Toothbrush, Powered
More FDA Info for this Device
510(K) Number
K012914
Device Name
Toothbrush, Powered
Applicant
HOMEDICS, INC.
3000 PONTIAC TRAIL
COMMERCE TOWNSHIP, MI 48390 US
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Contact
DAVID VANDERLIN
Other 510(k) Applications for this Contact
Regulation Number
872.6865
More FDA Info for this Regulation Number
Classification Product Code
JEQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2001
Decision Date
10/01/2001
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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