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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 K911825
Device Name TRIP(TM) NASOGASTRIC SUMP CATHETER
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 Received04/24/1991
Decision Date 07/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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