Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K212104 |
Device Name |
Water-soluble Personal Lubricant |
Applicant |
Foshan PingChuang Medical Technology Co., Ltd. |
Room 301, No. 3, Huaye Road, Lingang Pioneer Park, |
Shunjiang Neighborhood Committee, Beijiao |
Foshan,
CN
528312
|
|
Applicant Contact |
Huang Zhiyue |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
1713A, 17th Floor, Block A, Zhongguan Times Square, |
Nanshan District |
Shenzhen,
CN
518100
|
|
Correspondent Contact |
Joyce Yang |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/06/2021 |
Decision Date | 11/18/2021 |
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
|
|
|