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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 K090196
Device Name EG-3670URK
Applicant
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645 -1856
Applicant Contact PAUL SILVA
Correspondent
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645 -1856
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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