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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K111243
Device Name FUJINON ULTRASONIC PROCESSOR
Applicant
Fujinon, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact KATHERINE Y CHOI
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
ITX   IYN   IYO  
Date Received05/03/2011
Decision Date 05/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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