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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 K961070
Device Name ESOPHAGEAL MANOMETRY ANALYSIS MODULE
Applicant
SYNECTICS MEDICAL, INC.
1425 GREENWAY DR., #600
IRVING,  TX  75038
Applicant Contact ANNA PETTERSSON
Correspondent
SYNECTICS MEDICAL, INC.
1425 GREENWAY DR., #600
IRVING,  TX  75038
Correspondent Contact ANNA PETTERSSON
Regulation Number876.1725
Classification Product Code
KLA  
Subsequent Product Code
FFX  
Date Received03/18/1996
Decision Date 06/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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