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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, patient care
510(k) Number K210509
Device Name Rocket Platinum Cured Cathter
Applicant
Rocket Medical Plc
2-4 Sedling Road
Washington,  GB NE38 9BZ
Applicant Contact Tracy Charlton
Correspondent
Rocket Medical Plc
2-4 Sedling Road
Washington,  GB NE38 9BZ
Correspondent Contact Tracy Charlton
Regulation Number870.5050
Classification Product Code
DWM  
Subsequent Product Code
PNG  
Date Received02/22/2021
Decision Date 09/09/2021
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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