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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 K061068
Device Name EG-3670URK
Applicant
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645 -1856
Applicant Contact PAUL SILVA
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
ITX  
Date Received04/17/2006
Decision Date 05/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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