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FDA 510(k) Application Details - K081115
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K081115
Device Name
Media, Reproductive
Applicant
VITROLIFE SWEDEN AB
FAKTORVAGEN 13
KUNGSBACKA SE-434 37 SE
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Contact
KJELL KJORK
Other 510(k) Applications for this Contact
Regulation Number
884.6180
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Classification Product Code
MQL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2008
Decision Date
09/17/2008
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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