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FDA 510(k) Application Details - K081855
Device Classification Name
Devices, Breath Trapping, Alcohol
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510(K) Number
K081855
Device Name
Devices, Breath Trapping, Alcohol
Applicant
CANADA, INC.
1100 HAMMOND DR.
SUITE 410A-223
ATLANTA, GA 30328 US
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Contact
FEDERICO FORERO
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Regulation Number
862.3050
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Classification Product Code
DJZ
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More FDA Info for this Product Code
Date Received
06/30/2008
Decision Date
12/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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