Device Classification Name |
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device |
510(K) Number |
K221137 |
Device Name |
Lubricant, Patient, Vaginal, Latex Compatible |
Applicant |
InnoveMed Bio-tech Co., Ltd.
6F, No.184, Sec. 2, Chongqing N. Rd., Datong Dist.
Taipei 10357 CN
Other 510(k) Applications for this Company
|
Contact |
Linda 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 |
04/19/2022 |
Decision Date |
07/11/2023 |
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 |
|