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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 K771975
Device Name ARTERIAL BLOOD SAMPLING TRAY
Applicant
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1100
Classification Product Code
CBT  
Date Received10/17/1977
Decision Date 10/28/1977
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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