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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K841117
Device Name GASPAK PLUS DISPOS. HYDROGEN &
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received03/15/1984
Decision Date 04/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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