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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 K163321
Device Name Rocket Indwelling Pleural 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 Number870.5050
Classification Product Code
DWM  
Date Received11/25/2016
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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