Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K150584 |
Device Name |
Stryker Suture Tape |
Applicant |
Stryker |
5670 Greenwood Plaza Blvd, Suite 200 |
Greenwood Village,
CO
80111
|
|
Applicant Contact |
Taylor White |
Correspondent |
Stryker |
5670 Greenwood Plaza Blvd, Suite 200 |
Greenwood Village,
CO
80111
|
|
Correspondent Contact |
Taylor White |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/09/2015 |
Decision Date | 08/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|