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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 K850285
Device Name GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
Applicant
Premium Plastics, Inc.
Geneva Laboratories, Inc.
P.O. Box 140,
Elkhorn,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
Premium Plastics, Inc.
Geneva Laboratories, Inc.
P.O. Box 140,
Elkhorn,  WI  53121
Correspondent Contact GARY L SWANSON
Regulation Number876.5130
Classification Product Code
KOD  
Date Received01/23/1985
Decision Date 02/28/1985
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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