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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 K050094
Device Name LADY COMP USA
Applicant
Lady Comp USA
410 E. Terrace Heights
Jeffersonville,  IN  47130
Applicant Contact MICHAEL CARTAIN
Correspondent
Lady Comp USA
410 E. Terrace Heights
Jeffersonville,  IN  47130
Correspondent Contact MICHAEL CARTAIN
Classification Product Code
LHD  
Date Received01/14/2005
Decision Date 04/20/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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