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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 K060343
Device Name BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
Applicant
Sentech Korea Corp.
21 Grand Ave. Suite 103
Palisades Park,  NJ  07650
Applicant Contact MATTHEW H SON
Correspondent
Sentech Korea Corp.
21 Grand Ave. Suite 103
Palisades Park,  NJ  07650
Correspondent Contact MATTHEW H SON
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received02/10/2006
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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