Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K192144 |
Device Name |
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device |
Applicant |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876 -0151
|
|
Applicant Contact |
Eleanor Zhou |
Correspondent |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876 -0151
|
|
Correspondent Contact |
Joice Pappan |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 08/08/2019 |
Decision Date | 03/25/2020 |
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 |
Yes
|
|
|