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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K102847
Device Name DISPOSABLE ENDOMETRIAL SUCTION CURETTE
Applicant
Jiangsu Suyun Medical Materials Co., Ltd.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Jiangsu Suyun Medical Materials Co., Ltd.
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number884.1175
Classification Product Code
HHK  
Date Received09/29/2010
Decision Date 04/14/2011
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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