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510(k) K202134

Well Lead All Silicone Foley Catheter with Temperature Sensor by Well Lead Medical Co., Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2021
Date Received
July 31, 2020
Clearance Type
Special
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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