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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K082164
Device Name PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
Applicant
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Applicant Contact CHRISTIAN G QUASS
Correspondent
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN G QUASS
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/31/2008
Decision Date 10/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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