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FDA 510(k) Application Details - K150935
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K150935
Device Name
Catheter, Urethral
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411 US
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Contact
Meg Daniel
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
04/07/2015
Decision Date
07/02/2015
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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