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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 K030761
Device Name KAISHOU VAGINAL SPECULUM
Applicant
Jiangsu Kaishou Medical Apparatus Co., Ltd.
600 Liu Zhou Rd.
8 Bldg., 503 Rm.
Shanghai,  CN 200233
Applicant Contact GONG BO
Correspondent
Jiangsu Kaishou Medical Apparatus Co., Ltd.
600 Liu Zhou Rd.
8 Bldg., 503 Rm.
Shanghai,  CN 200233
Correspondent Contact GONG BO
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/11/2003
Decision Date 06/09/2003
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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