Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K122061 |
FOIA Releasable 510(k) |
K122061
|
Device Name |
K-Y BRAND LIQUIBEADS |
Applicant |
JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
185 TABOR ROAD |
MORRIS PLAINS,
NJ
07950
|
|
Applicant Contact |
LORNA-JANE BREMER |
Correspondent |
JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
185 TABOR ROAD |
MORRIS PLAINS,
NJ
07950
|
|
Correspondent Contact |
LORNA-JANE BREMER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/13/2012 |
Decision Date | 11/08/2013 |
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
|
|
|