Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K220355 |
Device Name |
Astroglide Ultra Gentle Gel |
Applicant |
BioFilm Inc. |
3225 Executive Ridge |
Vista,
CA
92081
|
|
Applicant Contact |
Kevin Jamil |
Correspondent |
BioFilm Inc. |
3225 Executive Ridge |
Vista,
CA
92081
|
|
Correspondent Contact |
Kevin Jamil |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/08/2022 |
Decision Date | 05/26/2022 |
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
|
|
|