Device Classification Name |
lubricant, personal
|
510(k) Number |
K190150 |
Device Name |
Sage 2-in-1 Personal Lubricant and Moisturizer |
Applicant |
Fairhaven Health, LLC |
1410 11th St |
Bellingham,
WA
98225
|
|
Applicant Contact |
Suzanne Munson |
Correspondent |
Fairhaven Health, LLC |
1410 11th St |
Bellingham,
WA
98225
|
|
Correspondent Contact |
Suzanne Munson |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/30/2019 |
Decision Date | 07/16/2019 |
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
|
|
|