Device Classification Name |
lubricant, personal
|
510(k) Number |
K203257 |
Device Name |
LUBi Water Based Personal Lubricant |
Applicant |
Boya Biotechnology Co., Ltd. |
Floor3,#7, Changfu Rd., Ludong Community, Humen Town |
Dongguan,
CN
523935
|
|
Applicant Contact |
Jason Lau |
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 | 11/04/2020 |
Decision Date | 12/23/2020 |
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
|
|
|