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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 K963484
Device Name BARD HIGH FLOW PAPILLOTOME
Applicant
Bard Interventional Products Div.
129 Concord Rd.
P.O. Box 7031
Billerica,  MA  01821
Applicant Contact BETH A ROCHETTE, R.A.C.
Correspondent
Bard Interventional Products Div.
129 Concord Rd.
P.O. Box 7031
Billerica,  MA  01821
Correspondent Contact BETH A ROCHETTE, R.A.C.
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/03/1996
Decision Date 11/19/1996
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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