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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, BADEN-WURTTEMBERG,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG,  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
Recalls CDRH Recalls
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