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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 K021978
Device Name PETIT SOPHIA
Applicant
Nishitomo Co., Inc.
3696 W. Main St.
Gray,  LA  70359
Applicant Contact LLOYD DUPLANTIS
Correspondent
Nishitomo Co., Inc.
3696 W. Main St.
Gray,  LA  70359
Correspondent Contact LLOYD DUPLANTIS
Classification Product Code
LHD  
Date Received06/17/2002
Decision Date 04/08/2003
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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