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510(k) K110627

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER by Marvao Medical Devices, Ltd. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2011
Date Received
March 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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