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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K925067
Device Name SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG
Applicant
Simport Plastics, Ltd.
Cardiff Business Park
Cardiff Cf4 5wf, U.K.
United Kingdom,  GB
Applicant Contact PAUL HALE
Correspondent
Simport Plastics, Ltd.
Cardiff Business Park
Cardiff Cf4 5wf, U.K.
United Kingdom,  GB
Correspondent Contact PAUL HALE
Regulation Number876.5250
Classification Product Code
KNX  
Date Received10/05/1992
Decision Date 06/10/1993
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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