Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K122735 |
Device Name |
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 |
Applicant |
SORIN GROUP USA INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Applicant Contact |
SCOTT LIGHT |
Correspondent |
SORIN GROUP USA INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Correspondent Contact |
SCOTT LIGHT |
Regulation Number | 878.5000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2012 |
Decision Date | 05/21/2013 |
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
|