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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K040981
FOIA Releasable 510(k) K040981
Device Name USW NEEDLEKNIFE PAPILLOTOME
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Applicant Contact MARGE WALLS-WALKER
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Correspondent Contact MARGE WALLS-WALKER
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/15/2004
Decision Date 05/07/2004
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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