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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K780939
Device Name BARD-PARKER ARTERIAL MONITORING SYSTEM
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 Number868.1100
Classification Product Code
CBT  
Date Received06/08/1978
Decision Date 07/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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