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FDA 510(k) Application Details - K201436
Device Classification Name
Stent, Ureteral
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510(K) Number
K201436
Device Name
Stent, Ureteral
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411 US
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Contact
Cori Ragan
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Regulation Number
876.4620
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Classification Product Code
FAD
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More FDA Info for this Product Code
Date Received
06/01/2020
Decision Date
02/25/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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