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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 K840986
Device Name PREFILLED PULSATOR SYRINGE
Applicant
CONCORD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CONCORD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1100
Classification Product Code
CBT  
Date Received03/07/1984
Decision Date 04/05/1984
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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