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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 K842690
Device Name SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT
Applicant
SYNECTICS AB
SIGTUNAGATAN 19
S-112 22 STOCKHOLM
SWEDEN,  SE
Applicant Contact ANDERS ESSEN-MOLLER
Correspondent
SYNECTICS AB
SIGTUNAGATAN 19
S-112 22 STOCKHOLM
SWEDEN,  SE
Correspondent Contact ANDERS ESSEN-MOLLER
Regulation Number876.1400
Classification Product Code
FFT  
Date Received07/10/1984
Decision Date 11/08/1984
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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