Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K122054 |
Device Name |
LIFESTYLES NATURAL PERSONAL LUBRICANT |
Applicant |
ANSELL HEALTHCARE PRODUCTS, LLC |
4 LOS VERDES DRIVE |
SAN LUIS OBISPO,
CA
93401
|
|
Applicant Contact |
DONNA DIGANGI |
Correspondent |
ANSELL HEALTHCARE PRODUCTS, LLC |
4 LOS VERDES DRIVE |
SAN LUIS OBISPO,
CA
93401
|
|
Correspondent Contact |
DONNA DIGANGI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/13/2012 |
Decision Date | 02/14/2013 |
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
|
|
|