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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 K941447
Device Name SIMPLA S4, S5, S7
Applicant
Simpla Plastics , Ltd.
Cardiff Business Park
Cardiff,  GB CF4 5WF
Applicant Contact RICHARD HUNTER
Correspondent
Simpla Plastics , Ltd.
Cardiff Business Park
Cardiff,  GB CF4 5WF
Correspondent Contact RICHARD HUNTER
Regulation Number876.5250
Classification Product Code
KNX  
Subsequent Product Code
EXJ  
Date Received03/24/1994
Decision Date 07/18/1994
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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