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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 K082080
Device Name ALCO TUBE PLUS
Applicant
Alcotest Quebec
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Alcotest Quebec
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received07/23/2008
Decision Date 04/01/2009
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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