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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, esophageal motility, anorectal motility, and tube
510(k) Number K872712
Device Name PC POLYGRAF
Applicant
SYNECTICS-DANTEC
1425 GREENWAY DR.
SUITE 600
IRVING,  TX  75038
Applicant Contact MARIA LENDAU
Correspondent
SYNECTICS-DANTEC
1425 GREENWAY DR.
SUITE 600
IRVING,  TX  75038
Correspondent Contact MARIA LENDAU
Regulation Number876.1725
Classification Product Code
KLA  
Date Received07/10/1987
Decision Date 03/18/1988
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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