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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 -1856
Applicant Contact LISA LANCIA
Correspondent
PENTAX MEDICAL COMPANY
102 CHESTNUT RIDGE RD.
MONTVALE,  NJ  07645 -1856
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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