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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 K061922
Device Name BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
Applicant
Sentech Korea Corp.
1460-1 Seoyang B/D
Seocho-Dong, Seocho-Ku
Seoul,  KR 13786
Applicant Contact DANIEL PARK
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received07/07/2006
Decision Date 10/30/2006
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 Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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