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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K080675
Device Name PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
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 Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
MRZ  
Date Received03/10/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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