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510(k) K173340

Yikang Latex Foley Catheter by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2018
Date Received
October 23, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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