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FDA 510(k), K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
FDA 510(k), K140667, WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
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510(K) Number: K140667
Device Name: WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
Manufacturer: HAN GUANG YUAN
Device Classification Name: Catheter, Retention Type, Balloon
Regulation Number: EZL
Classification Product Code: 03/18/2014
Date Received: 12/15/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
Manufacturer: HAN GUANG YUAN
Device Classification Name: Catheter, Retention Type, Balloon
Regulation Number: EZL
Classification Product Code: 03/18/2014
Date Received: 12/15/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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