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510(k) K110614

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM by Seju Engineering Co., Ltd. — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2011
Date Received
March 3, 2011
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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