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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 K050887
Device Name GONGDONG DISPOSABLE VAGINAL SPECULUM
Applicant
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
BEICHENG INDUSTRIAL AREA
HUANGYAN,  CN 318020
Applicant Contact WEIFENG ZHONG
Correspondent
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
BEICHENG INDUSTRIAL AREA
HUANGYAN,  CN 318020
Correspondent Contact WEIFENG ZHONG
Regulation Number884.4530
Classification Product Code
HIB  
Date Received04/07/2005
Decision Date 07/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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