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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Mask, Oxygen, Low Concentration, Venturi
510(k) Number K771385
Device Name 2 JET SET
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 Number868.5600
Classification Product Code
BYF  
Date Received07/27/1977
Decision Date 08/04/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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