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510(k) K063443

DRAEGER ALCOTEST 6510 by Drager Safety — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2008
Date Received
November 14, 2006
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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