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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biliary catheter for stone removal that may also allow for irrigation and contrast injection
510(k) Number K063677
Device Name FUSION QUATTRO EXTRACTION BALLOON XL
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact SCOTTIE FARIOLE
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact SCOTTIE FARIOLE
Regulation Number876.5010
Classification Product Code
GCA  
Date Received12/11/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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