Device Classification Name |
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device |
510(K) Number |
K220226 |
Device Name |
Lubricant, Patient, Vaginal, Latex Compatible |
Applicant |
R&R Medical Corporation Ltd
No.4, Ln. 38, Zhongxing N. St., Sanchong Dist.,
New Taipei City 24158 TW
Other 510(k) Applications for this Company
|
Contact |
Wilson Chang
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 |
01/27/2022 |
Decision Date |
03/28/2023 |
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 |
|