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510(k) K091516

WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR by Well Lead Medical Co., Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2009
Date Received
May 22, 2009
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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