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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 K214016
Device Name 15L Cycler Drainage Bag
Applicant
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield,  IL  60015
Applicant Contact Maninee Patel
Correspondent
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield,  IL  60015
Correspondent Contact Maninee Patel
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received12/22/2021
Decision Date 03/18/2022
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
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