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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K803185
Device Name NON-CONDUCTIVE ANESTHESIA FACE MASK
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 Number868.5550
Classification Product Code
BSJ  
Date Received12/16/1980
Decision Date 01/05/1981
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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