Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K051295 |
Device Name |
I-D GLIDE |
Applicant |
WESTRIDGE LABORATORIES INC. |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
WESTRIDGE LABORATORIES INC. |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/18/2005 |
Decision Date | 02/15/2006 |
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
|
|
|