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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 K963330
Device Name URODYNAMIC ANALYSIS MODULE
Applicant
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Applicant Contact ANNA PETTERSON
Correspondent
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Correspondent Contact ANNA PETTERSON
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/23/1996
Decision Date 04/03/1997
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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