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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 K123033
Device Name ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
Applicant
ROCKET MEDICAL PLC
FACTORIES 2& 4, SEDLING RD
WEAR INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE38 9BZ
Applicant Contact TRACY CHARLTON
Correspondent
ROCKET MEDICAL PLC
FACTORIES 2& 4, SEDLING RD
WEAR INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR,  GB NE38 9BZ
Correspondent Contact TRACY CHARLTON
Regulation Number870.5050
Classification Product Code
DWM  
Date Received09/28/2012
Decision Date 02/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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