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 Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/07/2005 |
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
|
|
|