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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 K982557
Device Name BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
Applicant
BARD INTERVENTIONAL PRODUCTS DIV.
129 CONCORD RD.
P.O. BOX 7031
BILLERICA,  MA  01821 -7031
Applicant Contact MARION GORDON
Correspondent
BARD INTERVENTIONAL PRODUCTS DIV.
129 CONCORD RD.
P.O. BOX 7031
BILLERICA,  MA  01821 -7031
Correspondent Contact MARION GORDON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/22/1998
Decision Date 09/10/1998
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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