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FDA 510(k) Application Details - K060343
Device Classification Name
Devices, Breath Trapping, Alcohol
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510(K) Number
K060343
Device Name
Devices, Breath Trapping, Alcohol
Applicant
SENTECH KOREA CORP.
21 GRAND AVE. SUITE 103
PALISADES PARK, NJ 07650 US
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Contact
MATTHEW H SON
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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
02/10/2006
Decision Date
05/11/2006
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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