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510(k) K093143

MISSION BREATH ALCOHOL DETECTOR by ACON Laboratories, Inc. — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2010
Date Received
October 5, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Breath Trapping, Alcohol
Device Class
Class I
Regulation Number
862.3050
Review Panel
TX
Submission Type

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