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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 K853059
Device Name LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
Applicant
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Applicant Contact CORRINE M AMBROSINO
Correspondent
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Correspondent Contact CORRINE M AMBROSINO
Regulation Number876.1620
Classification Product Code
FAP  
Date Received07/19/1985
Decision Date 01/10/1986
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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