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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 K192705
Device Name MiniCap Extended Life PD Transfer Sets
Applicant
Baxter Healthcare
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Kimberly Garcia
Correspondent
Baxter Healthcare
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Kimberly Garcia
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received09/27/2019
Decision Date 10/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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