Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K141776 |
Device Name |
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
PETER CECCHINI |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
PETER CECCHINI |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 07/02/2014 |
Decision Date | 10/15/2014 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|