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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 K895171
Device Name BLOOD GAS SAFETY SYRINGE
Applicant
Kronner Medical
544 W. Umpqua
Suite 104
Roseburg,  OR  97470
Correspondent
Kronner Medical
544 W. Umpqua
Suite 104
Roseburg,  OR  97470
Regulation Number868.1100
Classification Product Code
CBT  
Date Received08/10/1989
Decision Date 11/07/1989
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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