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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK102225
Test Name AlcoPro, Inc. Alco-Breath Tube .15%  
Manufacturer NameAlcopro, Inc.
Consumer Information Phone Number(800)227-9890
Test TypeAlcohol, breath
Effective Date04/07/2011
Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K102225
Device Name ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
Applicant
Alcopro, Inc.
1560 E. Edinger Ave.,
Suite B
Santa Ana,  CA  92705
Applicant Contact PERRY RUCKER
Correspondent
Alcopro, Inc.
1560 E. Edinger Ave.,
Suite B
Santa Ana,  CA  92705
Correspondent Contact PERRY RUCKER
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received08/09/2010
Decision Date 04/06/2011
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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