Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K063194 |
Device Name |
TUFFLEX POLYESTER SUTURE |
Applicant |
AXYA MEDICAL, INC. |
100 CUMMINGS CENTER |
SUITE 444C |
BEVERLY,
MA
01915
|
|
Applicant Contact |
HOWARD L SCHRAYER |
Correspondent |
AXYA MEDICAL, INC. |
100 CUMMINGS CENTER |
SUITE 444C |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
HOWARD L SCHRAYER |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 10/20/2006 |
Decision Date | 12/04/2006 |
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
|
|
|