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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K212505
Device Name DUMI ManipulatOR
Applicant
The O R Company Pty, Ltd.
1/32 Silkwood Pl.
Carrum Downs,  AU 3201
Applicant Contact Amesha Silva
Correspondent
The O R Company Pty, Ltd.
1/32 Silkwood Pl.
Carrum Downs,  AU 3201
Correspondent Contact Amesha Silva
Regulation Number884.4530
Classification Product Code
LKF  
Date Received08/09/2021
Decision Date 01/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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