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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K964804
Device Name FLEXILOG LS
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 Number876.1725
Classification Product Code
KLA  
Date Received11/29/1996
Decision Date 08/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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