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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 K063443
Device Name DRAEGER ALCOTEST 6510
Applicant
Drager Safety
333 Alpine St.
Emmaus,  PA  18049
Applicant Contact EVE DAMIANO
Correspondent
Drager Safety
333 Alpine St.
Emmaus,  PA  18049
Correspondent Contact EVE DAMIANO
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received11/14/2006
Decision Date 03/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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