Device Classification Name |
Dental Amalgam
|
510(k) Number |
K081273 |
Device Name |
ULTRACAPS S |
Applicant |
SDI LTD. |
5-9 BRUNSDON ST. |
BAYSWATER, VICTORIA,
AU
3153
|
|
Applicant Contact |
RAY CAHILL |
Correspondent |
SDI LTD. |
5-9 BRUNSDON ST. |
BAYSWATER, VICTORIA,
AU
3153
|
|
Correspondent Contact |
RAY CAHILL |
Regulation Number | 872.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/05/2008 |
Decision Date | 07/10/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|