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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 K961346
Device Name PH ANALYSIS MODULE
Applicant
Synectics-Dantec
Renstienas Gata 12, 5tr.
S-116 28 Stockholm
Sweden,  SE S-116 28
Applicant Contact ANN PETTERSSON
Correspondent
Synectics-Dantec
Renstienas Gata 12, 5tr.
S-116 28 Stockholm
Sweden,  SE S-116 28
Correspondent Contact ANN PETTERSSON
Regulation Number876.1400
Classification Product Code
FFT  
Subsequent Product Code
FFX  
Date Received03/15/1996
Decision Date 01/29/1997
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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