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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Coude
510(k) Number K946282
Device Name UNIVERSAL URETHRAL CATHETER
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Applicant Contact DAVID PHELPS
Correspondent
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Correspondent Contact DAVID PHELPS
Regulation Number876.5130
Classification Product Code
EZC  
Date Received12/27/1994
Decision Date 03/31/1995
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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