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FDA 510(k) Application Details - K102499
Device Classification Name
Device, Fertility Diagnostic, Proceptive
More FDA Info for this Device
510(K) Number
K102499
Device Name
Device, Fertility Diagnostic, Proceptive
Applicant
CAMBRIDGE TEMPERATURE CONCEPTS LTD.
P.O. BOX 390930
CAMBRIDGE, MA 02139 US
Other 510(k) Applications for this Company
Contact
SCOTT R MACKIE
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2010
Decision Date
12/20/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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