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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, External, Pressure, Amplifier & Transducer
510(k) Number K890284
Device Name URODEC 500
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Regulation Number876.1725
Classification Product Code
FES  
Date Received01/19/1989
Decision Date 05/30/1989
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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