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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 K071269
Device Name HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
Applicant
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Applicant Contact BARBARA LAW
Correspondent
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Correspondent Contact BARBARA LAW
Regulation Number868.1100
Classification Product Code
CBT  
Date Received05/07/2007
Decision Date 08/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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