Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K160717 |
Device Name |
ally Warming Liquid Personal Lubricant |
Applicant |
GUY & O'NEILL, INC. |
200 INDUSTRIAL DRIVE |
FREDONIA,
WI
53021
|
|
Applicant Contact |
THOMAS MISGEN |
Correspondent |
SPECTRAMEDEX, LLC |
3215 GOLF ROAD, #149 |
DELAFIELD,
WI
53018
|
|
Correspondent Contact |
JOHN ZIOBRO |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/15/2016 |
Decision Date | 06/14/2016 |
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
|
|
|