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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K091516
Device Name WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
Applicant
Well Lead Medical Co., Ltd.
962 Allegro Lane
Apollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Well Lead Medical Co., Ltd.
962 Allegro Lane
Apollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number876.5130
Classification Product Code
EZL  
Date Received05/22/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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