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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K152129
Device Name FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Applicant Contact TIFFANY LIN
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact TIFFANY LIN
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received07/31/2015
Decision Date 10/29/2015
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
Recalls CDRH Recalls
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