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510(k) K133615

WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER by Well Lead Medical Co., Ltd. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2014
Date Received
November 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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