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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 K063350
Device Name DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall-Strasse 01
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/06/2006
Decision Date 02/01/2008
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
Recalls CDRH Recalls
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