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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K902771
Device Name ARTERIAL BLOOD SAMPLING KIT
Applicant
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
MEDEX, INC.
3637 LACON RD.
HILLARD,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/21/1990
Decision Date 11/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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