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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 K800539
Device Name DISP. HYDROGEN & CO2 GENERATOR ENVELOPE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received03/10/1980
Decision Date 04/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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