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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K052912
Device Name YUSHENG DISPOSABLE VAGINAL SPECULUM
Applicant
Zhejiang Yusheng Medical Instrument Co. , Ltd.
Xuanmen Industrial Zone, Lupu
Town, Yuhuan County
Zhejiang Province, P.R.,  CN 317608
Applicant Contact PEIFANG XING
Correspondent
Zhejiang Yusheng Medical Instrument Co. , Ltd.
Xuanmen Industrial Zone, Lupu
Town, Yuhuan County
Zhejiang Province, P.R.,  CN 317608
Correspondent Contact PEIFANG XING
Regulation Number884.4530
Classification Product Code
HIB  
Date Received10/17/2005
Decision Date 12/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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