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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 K901512
Device Name L SOPHIA
Applicant
Nishitomo Co., Inc.
449-3, Hiruda, Tamaki-Cho
Watarai-Gun, Mie-Pref.
Japan,  JP 519-0423
Applicant Contact NISHIMURA
Correspondent
Nishitomo Co., Inc.
449-3, Hiruda, Tamaki-Cho
Watarai-Gun, Mie-Pref.
Japan,  JP 519-0423
Correspondent Contact NISHIMURA
Classification Product Code
LHD  
Date Received03/29/1990
Decision Date 07/20/1990
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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