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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pill, Radio
510(k) Number K840934
Device Name MEDILOG PH1
Applicant
Oxford Medilog, Inc.
Coral Gables,  FL 
Correspondent
Oxford Medilog, Inc.
Coral Gables,  FL 
Regulation Number876.1725
Classification Product Code
EXW  
Date Received03/05/1984
Decision Date 06/28/1984
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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