Device Classification Name |
lubricant, personal
|
510(k) Number |
K162207 |
FOIA Releasable 510(k) |
K162207
|
Device Name |
Restore Moisturizing Vaginal Lubricant |
Applicant |
Good Clean Love |
207 West 5th Avenue |
Eugene,
OR
97401
|
|
Applicant Contact |
Wendy Strgar |
Correspondent |
S. Hesler Compliance Engineering |
2602 5th Ave |
West Linn,
OR
97068
|
|
Correspondent Contact |
Steve Hesler |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/05/2016 |
Decision Date | 05/04/2017 |
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
|
|
|