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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 K100879
Device Name CONTRALCO
Applicant
Contralco
144 Research Dr.
Hampton,  VA  23666
Applicant Contact CAMILLE D THORNTON
Correspondent
Contralco
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact CAMILLE D THORNTON
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received03/30/2010
Decision Date 08/04/2010
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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