Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K010673 |
Device Name |
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 |
Applicant |
ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. |
NAPLES,
FL
34104
|
|
Applicant Contact |
BRETTE MASINO |
Correspondent |
ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. |
NAPLES,
FL
34104
|
|
Correspondent Contact |
BRETTE MASINO |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/06/2001 |
Decision Date | 05/14/2001 |
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
|
|
|