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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 AVENUE,
SUITE B
SANTA ANA,  CA  92705
Applicant Contact PERRY RUCKER
Correspondent
ALCOPRO, INC.
1560 E. EDINGER AVENUE,
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
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