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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K090631
Device Name PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
Applicant
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG,  DE 78187
Applicant Contact CHRISTIAN G QUASS
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG,  DE 78187
Correspondent Contact CHRISTIAN G QUASS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/09/2009
Decision Date 04/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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