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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 K113771
Device Name SIGNAL GEAR URETHRAL CATHETER ELECTRODE
Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE
SUITE 1000
VENTURA,  CA  93003
Applicant Contact CHRISTINE VERGELY
Correspondent
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE
SUITE 1000
VENTURA,  CA  93003
Correspondent Contact CHRISTINE VERGELY
Regulation Number876.1620
Classification Product Code
FAP  
Date Received12/22/2011
Decision Date 12/13/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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