Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K162569 |
FOIA Releasable 510(k) |
K162569
|
Device Name |
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer |
Applicant |
BIOTECH LUBRICANTS LTD |
TRADEMARK HOUSE, RAMSHILL |
Petersfield,
GB
GU31 4AT
|
|
Applicant Contact |
Sarah Brooks |
Correspondent |
MAETRICS |
BIOCITY NOTTINGHAM, PENNYFOOT STREET |
Nottingham,
GB
NG1 1GF
|
|
Correspondent Contact |
Karen Cornelius |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/15/2016 |
Decision Date | 06/09/2017 |
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
|
|
|