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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K900494
Device Name SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
Applicant
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Applicant Contact ANDERS ESSEN-MOLLER
Correspondent
Synectics-Dantec
1425 Greenway Dr.
Suite 600
Irving,  TX  75038
Correspondent Contact ANDERS ESSEN-MOLLER
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/02/1990
Decision Date 06/11/1990
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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