Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K163674 |
Device Name |
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry |
Applicant |
NEO COSMETIQUE |
15 RUE MONTJOIE |
SAINT DENIS,
FR
93212
|
|
Applicant Contact |
NATHALIE VERNIN |
Correspondent |
TECHNIC INC |
47 MOLTER AVE |
CRANSTON,
RI
02910
|
|
Correspondent Contact |
GAYLE LYNE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/27/2016 |
Decision Date | 09/22/2017 |
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
|
|
|