Device Classification Name |
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device |
510(K) Number |
K190752 |
Device Name |
Lubricant, Patient, Vaginal, Latex Compatible |
Applicant |
FemmePharma Consumer Healthcare, LLC
175 Strafford Ave., Bldg 4, Suite 275
Wayne, PA 19087 US
Other 510(k) Applications for this Company
|
Contact |
Gerianne DiPiano
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 |
03/25/2019 |
Decision Date |
12/13/2019 |
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 |
|