Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K124044 |
FOIA Releasable 510(k) |
K124044
|
Device Name |
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS |
Applicant |
SEVEN OAKS RANCH, INC. |
2658 CHANNEL DRIVE |
VENTURA,
CA
93003
|
|
Applicant Contact |
Calley Herzog |
Correspondent |
SEVEN OAKS RANCH, INC. |
2658 CHANNEL DRIVE |
VENTURA,
CA
93003
|
|
Correspondent Contact |
Calley Herzog |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/31/2012 |
Decision Date | 08/30/2013 |
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
|
|
|