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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 K923995
Device Name URODYNAMICS TUBING KITS #5161, #5150, #7170
Applicant
Advanced Medical Products, Inc.
P.O. Box 10040
Merrillville,  IN  46411
Applicant Contact JOEL J ROSEN
Correspondent
Advanced Medical Products, Inc.
P.O. Box 10040
Merrillville,  IN  46411
Correspondent Contact JOEL J ROSEN
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/10/1992
Decision Date 04/08/1993
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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