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FDA 510(k) Application Details - K101003
Device Classification Name
Media, Reproductive
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510(K) Number
K101003
Device Name
Media, Reproductive
Applicant
VITROLIFE SWEDEN AB
BOX 9080
SE-400 92 GOTEBORG 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
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More FDA Info for this Product Code
Date Received
04/12/2010
Decision Date
12/10/2010
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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