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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Suction, Uterine
510(k) Number K093508
Device Name RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
Applicant
Womancare Global
300 Market St. Suite 134
Chapel Hill,  NC  27516
Applicant Contact Susanne Parks
Correspondent
Womancare Global
300 Market St. Suite 134
Chapel Hill,  NC  27516
Correspondent Contact Susanne Parks
Regulation Number884.5070
Classification Product Code
HGH  
Date Received11/12/2009
Decision Date 03/04/2010
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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