Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K193448 |
Device Name |
BioNourish Lubricant |
Applicant |
Good Clean Love, Inc. |
207 W 5th Avenue |
Eugene,
OR
97401
|
|
Applicant Contact |
Weny Strgar |
Correspondent |
Amin Talati Wasserman, LLP |
100 S Wacker Drive, Suite 2000 |
Chicago,
IL
60606
|
|
Correspondent Contact |
Abhishek Gurnani |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/13/2019 |
Decision Date | 03/12/2020 |
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
|
|
|