FDA.report

510(k) K030761

Device
KAISHOU VAGINAL SPECULUM
Applicant
Jiangsu Kaishou Medical Apparatus Co., Ltd.
510(k) number
K030761
Product code
HIB
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-09
Date received
2003-03-11
Regulation
884.4530
Classification name
Speculum, Vaginal, Nonmetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GONG BO
Address
600 Liu Zhou Rd. 8 Bldg., 503 Rm. Shanghai CN 200233 200233

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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