Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K013990 |
Device Name |
LIFESTITCH SUTURING DEVICE |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
LUCINDA STOCKERT |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
LUCINDA STOCKERT |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 12/03/2001 |
Decision Date | 02/27/2002 |
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
|
|
|