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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 K883234
Device Name TONOMITOR (TM) + SUMP
Applicant
Tonometrics, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact DONALD L MACKEEN
Correspondent
Tonometrics, Inc.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact DONALD L MACKEEN
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/01/1988
Decision Date 10/12/1988
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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