Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K191411 |
Device Name |
Ah!Yes Ob Coco Personal Lubricant |
Applicant |
Bio-Tech Lubricants Ltd |
C/O Epsilon House, Enterprise Road, |
Southampton Science Park |
Southampton,
GB
SO16 7NS
|
|
Applicant Contact |
Sarah Brooks |
Correspondent |
Bio-Tech Lubricants Ltd |
C/O The Timber Barn, Selborne Road |
Greatham, Liss,
GB
GU33 6HG
|
|
Correspondent Contact |
Karen Cornelius |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/28/2019 |
Decision Date | 02/06/2020 |
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
|
|
|