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FDA 510(k), K152129, FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
FDA 510(k), K152129, FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
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510(K) Number: K152129
Device Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Manufacturer: TIFFANY LIN
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: 07/31/2015
Date Received: 10/29/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Manufacturer: TIFFANY LIN
Device Classification Name: Set, Administration, For Peritoneal Dialysis, Disposable
Regulation Number: KDJ
Classification Product Code: 07/31/2015
Date Received: 10/29/2015
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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