Device Classification Name |
material, impression
|
510(k) Number |
K974704 |
Device Name |
HYDROGUM |
Applicant |
ZHERMACK S.P.A. |
7527 WESTMORELAND AVE. |
ST. LOUIS,
MO
63105
|
|
Applicant Contact |
EVAN DICK |
Correspondent |
ZHERMACK S.P.A. |
7527 WESTMORELAND AVE. |
ST. LOUIS,
MO
63105
|
|
Correspondent Contact |
EVAN DICK |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 12/16/1997 |
Decision Date | 01/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|