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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K110614
Device Name PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
Applicant
Seju Engineering Co., Ltd.
Certification Division
D-524 Migun Techno World2,
Yuseong-Gu, Daejeon,  KR 305-500
Applicant Contact EILEEN YANG
Correspondent
Seju Engineering Co., Ltd.
Certification Division
D-524 Migun Techno World2,
Yuseong-Gu, Daejeon,  KR 305-500
Correspondent Contact EILEEN YANG
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received03/03/2011
Decision Date 11/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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