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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 K902632
Device Name GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
Applicant
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Applicant Contact L JOHNSON
Correspondent
Marquest Medical Products, Inc.
11039 E. Lansing Cir.
Englewood,  CO  80112
Correspondent Contact L JOHNSON
Regulation Number868.1100
Classification Product Code
CBT  
Date Received06/14/1990
Decision Date 09/04/1990
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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