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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K211911
Device Name Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Angela Kilian
Correspondent
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Angela Kilian
Classification Product Code
LJE  
Subsequent Product Code
FAD  
Date Received06/21/2021
Decision Date 03/10/2022
Decision Substantially Equivalent - Kit (SESK)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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