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510(k) K081855

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) by Canada, Inc. — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
June 30, 2008
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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