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510(k) K102833

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS by Foshan Nanhai Bai HE Medical Technology Co., Ltd. — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
September 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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