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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 K002726
Device Name TCOYF FERTILITY SOFTWARE VERSION 1.0
Applicant
Ovusoft, LLC
402 Dunham Massie Dr.
Hampton,  VA  23669 -1744
Applicant Contact GENE GRANT
Correspondent
Ovusoft, LLC
402 Dunham Massie Dr.
Hampton,  VA  23669 -1744
Correspondent Contact GENE GRANT
Classification Product Code
LHD  
Date Received08/31/2000
Decision Date 04/06/2001
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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