Device Classification Name |
Suture, Surgical, Absorbable, Polydioxanone
|
510(k) Number |
K040004 |
Device Name |
ORTHOCORD SUTURE |
Applicant |
Depuy Mitek |
249 VANDERBILT DR. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
RUTH C FORSTADT |
Correspondent |
Depuy Mitek |
249 VANDERBILT DR. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
RUTH C FORSTADT |
Regulation Number | 878.4840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/02/2004 |
Decision Date | 04/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|