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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K770851
Device Name SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016
Original Applicant
CONCORD LABORATORIES, INC.
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/09/1977
Decision Date 07/14/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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