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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 K080654
Device Name PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
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 Number876.1500
Classification Product Code
GCJ  
Date Received03/07/2008
Decision Date 05/08/2008
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
Predetermined Change
Control Plan Authorized		 No
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