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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 K853648
Device Name SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO
Applicant
Synectics-Dantec
333 N. Michigan Ave. #2315
Chicago,  IL  60601
Applicant Contact ANERS ESSEN-MOLLER
Correspondent
Synectics-Dantec
333 N. Michigan Ave. #2315
Chicago,  IL  60601
Correspondent Contact ANERS ESSEN-MOLLER
Regulation Number876.1400
Classification Product Code
FFT  
Date Received09/03/1985
Decision Date 11/18/1985
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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