Device Classification Name |
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device |
510(K) Number |
K210857 |
Device Name |
Lubricant, Patient, Vaginal, Latex Compatible |
Applicant |
Shenzhen Huanqiu Xuebao Technology Co., Ltd.
Room 303, Building 2, Lane 2, Jinjuxia Road, Bao'an Avenue
Fuyong Street
Bao'an District Shenzhen 518100 CN
Other 510(k) Applications for this Company
|
Contact |
Jiao Li
Other 510(k) Applications for this Contact |
Regulation Number |
884.5300
More FDA Info for this Regulation Number |
Classification Product Code |
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/23/2021 |
Decision Date |
09/24/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OB - Obstetrics/Gynecology |
Review Advisory Committee |
OB - Obstetrics/Gynecology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|