Device Classification Name |
lubricant, personal
|
510(k) Number |
K151884 |
Device Name |
K-Y Marilyn Pleasure Gel |
Applicant |
Reckitt Benckiser LLC |
399 Interpace Parkway |
Parsippany,
NJ
07054
|
|
Applicant Contact |
ELIZABETH TORRE |
Correspondent |
Reckitt Benckiser LLC |
399 Interpace Parkway |
Parsippany,
NJ
07054
|
|
Correspondent Contact |
ELIZABETH TORRE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/09/2015 |
Decision Date | 01/11/2016 |
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
|
|
|