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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
510(k) Number K162457
Device Name Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Applicant
Rocket Medical Plc
2-4 Sedling Rd., Wear Industrial Estate
Washington,  GB NE38 9BZ
Applicant Contact Tracy Charlton
Correspondent
Rocket Medical Plc
2-4 Sedling Rd., Wear Industrial Estate
Washington,  GB NE38 9BZ
Correspondent Contact Tracy Charlton
Regulation Number876.5630
Classification Product Code
PNG  
Date Received09/02/2016
Decision Date 11/14/2016
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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