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FDA 510(k) Application Details - K173624
Device Classification Name
Media, Reproductive
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510(K) Number
K173624
Device Name
Media, Reproductive
Applicant
Origio a/s
Knardrupvej 2
Malov 2760 DK
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Contact
Tove Kjaer
Other 510(k) Applications for this Contact
Regulation Number
884.6180
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Classification Product Code
MQL
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More FDA Info for this Product Code
Date Received
11/24/2017
Decision Date
03/02/2018
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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