Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K143349 |
Device Name |
Gynomunal |
Applicant |
POLICHEM S.A. |
VIA SENAGO 42D |
LUGANO-PAZZALLO,
CH
6912
|
|
Applicant Contact |
Daria Mari |
Correspondent |
RQMIS, INC. |
29 WATER STREET |
SUITE 305 |
NEWBURYPORT,
MA
01950
|
|
Correspondent Contact |
Barry E Sands |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 11/24/2014 |
Decision Date | 09/16/2015 |
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
|
|
|