Device Classification Name |
Condom
|
510(k) Number |
K013086 |
Device Name |
WET LIGHT PERSONAL MOISTURIZER |
Applicant |
TRIGG LABORATORIES, INC. |
WARNER CENTER PLAZA |
21800 OXNARD STREET, SUITE 840 |
WOODLAND HILLS,
CA
91367
|
|
Applicant Contact |
W. PATRICK NOONAN |
Correspondent |
TRIGG LABORATORIES, INC. |
WARNER CENTER PLAZA |
21800 OXNARD STREET, SUITE 840 |
WOODLAND HILLS,
CA
91367
|
|
Correspondent Contact |
W. PATRICK NOONAN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/14/2001 |
Decision Date | 12/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|