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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 K150519
Device Name ManipulatOR PRO, ManipulatOR
Applicant
GYNETECH PTY. LTD.
122-124 Balmain Street
Richmond,  AU 3121
Applicant Contact Brett Telford
Correspondent
QUINTILES CONSULTING
1801 ROCKVILLE PIKE, SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact Christopher M Sloan
Regulation Number884.4530
Classification Product Code
LKF  
Date Received03/02/2015
Decision Date 08/19/2015
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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