Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K122374 |
Device Name |
ARTHREX SUTURE (UHMWPE) |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
IVETTE GALMEZ |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
IVETTE GALMEZ |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 08/06/2012 |
Decision Date | 09/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|