Device Classification Name |
prosthesis, adhesive, external
|
510(k) Number |
K934970 |
Device Name |
DUET |
Applicant |
TRULIFE LTD. |
3 COOKSTOWN INDUSTRIAL ESTATE |
TALLAGHT |
DUBLIN 24,
IE
|
|
Applicant Contact |
JEAN TWOHIG |
Correspondent |
TRULIFE LTD. |
3 COOKSTOWN INDUSTRIAL ESTATE |
TALLAGHT |
DUBLIN 24,
IE
|
|
Correspondent Contact |
JEAN TWOHIG |
Regulation Number | 878.3750
|
Classification Product Code |
|
Date Received | 10/18/1993 |
Decision Date | 12/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|