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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K133615
Device Name WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
Applicant
Well Lead Medical Co., Ltd.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact JOHN OBRIEN
Correspondent
Well Lead Medical Co., Ltd.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JOHN OBRIEN
Regulation Number876.5130
Classification Product Code
EZD  
Date Received11/25/2013
Decision Date 02/24/2014
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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