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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 K990376
Device Name BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact E. MARTIN CHAMBERLAIN
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact E. MARTIN CHAMBERLAIN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/08/1999
Decision Date 05/03/1999
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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