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510(k) K043188

ALCOHAWK PRECISION by Q3 Innovations, LLC — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2005
Date Received
November 17, 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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