Device Classification Name |
suture, nonabsorbable, synthetic, polyester
|
510(k) Number |
K091018 |
Device Name |
ARTHREX BIOWIRE |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
SALLY FOUST |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
SALLY FOUST |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 04/09/2009 |
Decision Date | 07/30/2010 |
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
|
|
|