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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K092710
Device Name PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Applicant
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645
Applicant Contact LISA LANCIA
Correspondent
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645
Correspondent Contact LISA LANCIA
Regulation Number876.1500
Classification Product Code
FDT  
Date Received09/03/2009
Decision Date 12/02/2009
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
Recalls CDRH Recalls
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