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FDA 510(k) Application Details - K182122
Device Classification Name
Catheter, Ureteral, Gastro-Urology
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510(K) Number
K182122
Device Name
Catheter, Ureteral, Gastro-Urology
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
876.5130
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Classification Product Code
EYB
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More FDA Info for this Product Code
Date Received
08/06/2018
Decision Date
10/04/2018
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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