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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ph, Stomach
510(k) Number K896288
Device Name FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
Applicant
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Applicant Contact JOHN GIDDINGS
Correspondent
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Correspondent Contact JOHN GIDDINGS
Regulation Number876.1400
Classification Product Code
FFT  
Date Received10/30/1989
Decision Date 05/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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