Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K100572 |
Device Name |
VERSACLOSE, MODEL VC-200-01 |
Applicant |
ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
RACHEL KENNEDY |
Correspondent |
ANULEX TECHNOLOGIES, INC |
5600 ROWLAND ROAD, STE 280 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
RACHEL KENNEDY |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/01/2010 |
Decision Date | 03/17/2010 |
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
|
|
|