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FDA 510(k) Application Details - K053646
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K053646
Device Name
Media, Reproductive
Applicant
SAGE IN-VITRO FERTILIZATION INC.
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact
GRACE HOLLAND
Other 510(k) Applications for this Contact
Regulation Number
884.6180
More FDA Info for this Regulation Number
Classification Product Code
MQL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2005
Decision Date
07/14/2006
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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