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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, catheter, ureteral
510(k) Number K201007
Device Name In-Ka Ureteral Balloon Dilatation Catheter
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Cori Ragan
Correspondent
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Cori Ragan
Regulation Number876.5470
Classification Product Code
EZN  
Date Received04/17/2020
Decision Date 06/11/2020
Decision Substantially Equivalent - Kit (SESK)
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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