Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K041216 |
Device Name |
SMITH & NEPHEW ULTRABRAID SUTURE |
Applicant |
SMITH & NEPHEW, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DENISE LIMA |
Correspondent |
SMITH & NEPHEW, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DENISE LIMA |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 06/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|