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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K884061
Device Name ADD-A-CATH
Applicant
Femcare , Ltd.
Bar Ln. Industrial Park
Bar Ln., Basford
Nottingham, England,  GB NG6 0JA
Applicant Contact ANDREW MARTIN
Correspondent
Femcare , Ltd.
Bar Ln. Industrial Park
Bar Ln., Basford
Nottingham, England,  GB NG6 0JA
Correspondent Contact ANDREW MARTIN
Regulation Number876.5090
Classification Product Code
KOB  
Date Received09/26/1988
Decision Date 10/25/1988
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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