Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K182142 |
Device Name |
FEMME Applicator Tampon |
Applicant |
Jiangsu YOAI Technology co., Ltd. |
Building No.3, No.33 Jing You Road, Jiangning District |
Nanjing,
CN
211100
|
|
Applicant Contact |
Huan Wang |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
Room 1122, No. 55 Shizhou Middle Road, |
Nanshan District |
Shenzhen,
CN
GD755
|
|
Correspondent Contact |
Field Fu |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 08/07/2018 |
Decision Date | 08/28/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|