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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K090197
Device Name EG-3870UTK
Applicant
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645
Applicant Contact PAUL SILVA
Correspondent
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645
Correspondent Contact PAUL SILVA
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received01/27/2009
Decision Date 05/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
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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