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FDA 510(k) Application Details - K213186
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K213186
Device Name
Stent, Ureteral
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411 US
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Contact
Gayatri Ghadge
Other 510(k) Applications for this Contact
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
09/29/2021
Decision Date
02/16/2022
Decision
SESK - SUBST EQUIV - KIT
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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