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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 K022595
Device Name WILSON-COOK CYSTOTOME
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact MARGARET J POSNER
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact MARGARET J POSNER
Regulation Number876.4300
Classification Product Code
KNS  
Date Received08/05/2002
Decision Date 10/17/2002
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
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