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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, urological
510(k) Number K864592
Device Name JUDD URETHAL CATHETER CONTAINER
Applicant
PHIL JUDD, INC.
1500 s.w. 5th ave., suite 1806
portland,  OR  97201 -5458
Applicant Contact kenneth m judd
Correspondent
PHIL JUDD, INC.
1500 s.w. 5th ave., suite 1806
portland,  OR  97201 -5458
Correspondent Contact kenneth m judd
Regulation Number876.5130
Classification Product Code
KOD  
Date Received11/21/1986
Decision Date 06/24/1987
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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