Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K133336 |
Device Name |
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE |
Applicant |
PJUR GROUP,LUXEMBOURG S.A. |
722 ARJEAN DR. |
WILMINGTON,
NC
28411
|
|
Applicant Contact |
CANDACE CEDERMAN |
Correspondent |
PJUR GROUP,LUXEMBOURG S.A. |
722 ARJEAN DR. |
WILMINGTON,
NC
28411
|
|
Correspondent Contact |
CANDACE CEDERMAN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/29/2013 |
Decision Date | 07/24/2014 |
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
|
|
|