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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 K070340
Device Name SECURE 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 Received02/06/2007
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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