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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 K012771
Device Name TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
Applicant
PAJUNK GMBH
AM HOLZPLATZ 5-7
GEISINGEN,  DE D-78187
Applicant Contact MARTIN HANGER
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/17/2001
Decision Date 11/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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