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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K113209
Device Name CHIBA SONO
Applicant
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received10/31/2011
Decision Date 11/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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