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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K810023
Device Name HYDROPHILIC COATED CATHETER
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 Number868.6810
Classification Product Code
BSY  
Date Received01/05/1981
Decision Date 02/06/1981
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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