Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K120650 |
Device Name |
POISE PERSONAL LUBRICANT |
Applicant |
KIMBERLY-CLARK CORPORATION |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
Swarna Mukund |
Correspondent |
KIMBERLY-CLARK CORPORATION |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
Swarna Mukund |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/02/2012 |
Decision Date | 07/11/2012 |
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
|
|
|