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FDA 510(k) Application Details - K173527
Device Classification Name
More FDA Info for this Device
510(K) Number
K173527
Device Name
Digitex Delivery Device
Applicant
Coloplast A/S
1601 West River Road North
Minneapolis, MN 55411 US
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Contact
Nikita Basandra
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Regulation Number
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Classification Product Code
PWI
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More FDA Info for this Product Code
Date Received
11/14/2017
Decision Date
02/12/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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