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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 K913817
Device Name MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
Applicant
SYNECTICS-DANTEC
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM
SWEDEN,  SE S-116 28
Applicant Contact ANNA PETTERSSON
Correspondent
SYNECTICS-DANTEC
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM
SWEDEN,  SE S-116 28
Correspondent Contact ANNA PETTERSSON
Regulation Number876.1400
Classification Product Code
FFT  
Date Received08/26/1991
Decision Date 06/11/1992
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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