Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K151647 |
Device Name |
Uberlube |
Applicant |
UBERLUBE LLC |
2611 HARTZELL STREET |
EVANSTON,
IL
60201
|
|
Applicant Contact |
JACK MAGNUSEN |
Correspondent |
SPECTRAMEDEX LLC |
117 WEST SOUTH STREET |
OCONOMOWOC,
WI
53066
|
|
Correspondent Contact |
JOHN ZIOBRO |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/18/2015 |
Decision Date | 09/23/2015 |
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
|
|
|