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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 -8619
Applicant Contact FRANK FERGUSON
Correspondent
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
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
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