Device Classification Name |
lubricant, personal
|
510(k) Number |
K033776 |
Device Name |
INSTEAD INTIMATE LUBRICANT |
Applicant |
INSTEAD, INC. |
4370 LA JOLLA VILLAGE DR. |
SUITE 960 |
SAN DIEGO,
CA
92122
|
|
Applicant Contact |
JOE PIKE |
Correspondent |
INSTEAD, INC. |
4370 LA JOLLA VILLAGE DR. |
SUITE 960 |
SAN DIEGO,
CA
92122
|
|
Correspondent Contact |
JOE PIKE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/03/2003 |
Decision Date | 06/25/2004 |
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
|
|
|