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510(k) K091714

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 by Skyfine Inc. Limited — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2009
Date Received
June 10, 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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