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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 K080946
Device Name CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
Applicant
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Applicant Contact BETH ZIS
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/03/2008
Decision Date 05/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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