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FDA 510(k) Application Details - K223821
Device Classification Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
More FDA Info for this Device
510(K) Number
K223821
Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant
Coloplast
1601 West River Road North
Minneapolis, MN 55411 US
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Contact
Preeti Jain
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
FCM
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More FDA Info for this Product Code
Date Received
12/21/2022
Decision Date
08/02/2023
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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