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FDA 510(k) Application Details - K023254
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K023254
Device Name
Catheter, Urethral
Applicant
COLOPLAST CORP.
1940 COMMERCE DR.
NORTH MANKATO, MN 56003 US
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Contact
ELIZABETH BOOTS
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
GBM
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More FDA Info for this Product Code
Date Received
09/30/2002
Decision Date
01/27/2003
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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