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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K180469
Device Name ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
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 Number876.4620
Classification Product Code
FAD  
Date Received02/21/2018
Decision Date 11/06/2018
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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