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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 K831034
Device Name QUALISTICK ARTERIAL BLOOD SAMPLER
Applicant
Radiometer America, Inc.
Mentor,  OH 
Correspondent
Radiometer America, Inc.
Mentor,  OH 
Regulation Number868.1100
Classification Product Code
CBT  
Date Received03/31/1983
Decision Date 05/18/1983
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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