FDA 510(k) K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER, by Well Lead Medical Co., Ltd.
FDA 510(k) K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER, by Well Lead Medical Co., Ltd.
Device Classification Name: Catheter, Retention Type, Balloon
510(k) Number: K140667
Device Name: WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
Applicant: Well Lead Medical Co., Ltd.
Regulation Number: 876.5130
Classification Product Code: EZL
Date Received: 03/18/2014
Decision Date: 12/15/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 447
Fully redacted pages: 276
Content pages: 171
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