Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K021834 |
Device Name |
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE |
Applicant |
MLE, INC. |
10 GREENLAWN AVE. |
S. GRAFTON,
MA
01560
|
|
Applicant Contact |
CHRISTINE E NICHOLS |
Correspondent |
MLE, INC. |
10 GREENLAWN AVE. |
S. GRAFTON,
MA
01560
|
|
Correspondent Contact |
CHRISTINE E NICHOLS |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 06/04/2002 |
Decision Date | 08/28/2002 |
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
|
|
|