Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K132043 |
Device Name |
ARTHREX SPEEDCINCH |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
LEON BROWN II, PH.D. |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
LEON BROWN II, PH.D. |
Regulation Number | 878.5000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2013 |
Decision Date | 07/31/2013 |
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
|
|
|