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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 K870528
Device Name OVU-TRAC OVULATION TIMING KIT
Applicant
Ob/Gyn Concepts, Ltd.
613 Dock Dr.
Barrington,  IL  60010
Applicant Contact CHARLES B ROOT
Correspondent
Ob/Gyn Concepts, Ltd.
613 Dock Dr.
Barrington,  IL  60010
Correspondent Contact CHARLES B ROOT
Classification Product Code
LHD  
Date Received02/05/1987
Decision Date 05/06/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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