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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 K880618
Device Name FERTILITY FORECASTER COMPUTER PROGRAM
Applicant
Fertile Time, Ltd.
92 Stone Hurst Ln.
Dix Hills,  NY  11746
Applicant Contact SUSAN NUDELMAN
Correspondent
Fertile Time, Ltd.
92 Stone Hurst Ln.
Dix Hills,  NY  11746
Correspondent Contact SUSAN NUDELMAN
Classification Product Code
LHD  
Date Received02/16/1988
Decision Date 06/24/1988
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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