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FDA 510(k) Application Details - K110888
Device Classification Name
Heat Source For Bleaching Teeth
More FDA Info for this Device
510(K) Number
K110888
Device Name
Heat Source For Bleaching Teeth
Applicant
DR. FRESH, INC.
12101 CULLEN BLVD
HOUSTON, TX 77047-1131 US
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Contact
M. JOYCE HEINRICH
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Regulation Number
872.6475
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Classification Product Code
EEG
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More FDA Info for this Product Code
Date Received
03/30/2011
Decision Date
01/12/2012
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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