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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fertility Diagnostic, Proceptive
510(k) Number K102499
Device Name DUOFERTILITY
Applicant
Cambridge Temperature Concepts , Ltd.
P.O. Box 390930
Cambridge,  MA  02139
Applicant Contact SCOTT R MACKIE
Correspondent
Cambridge Temperature Concepts , Ltd.
P.O. Box 390930
Cambridge,  MA  02139
Correspondent Contact SCOTT R MACKIE
Classification Product Code
LHD  
Date Received08/31/2010
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01343199
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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