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510(k) K041334

ALCOMATE, MODEL CA2000 by Khn Solutions, LLC — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2004
Date Received
May 19, 2004
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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  • K071067 — BACTRACK LCD ALCOHOL DETECTOR (September 14, 2007)

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