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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K023218
Device Name MODIFICATION TO PLEXOLONG SETS
Applicant
Pajunk GmbH
5010 NW Crescent Valley Dr.
Corvallis,  OR  97330
Applicant Contact BURK BRANDT
Correspondent
Pajunk GmbH
5010 NW Crescent Valley Dr.
Corvallis,  OR  97330
Correspondent Contact BURK BRANDT
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
CAZ  
Date Received09/26/2002
Decision Date 03/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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