Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K181652 |
Device Name |
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture |
Applicant |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876 -0151
|
|
Applicant Contact |
Donna Marshall |
Correspondent |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876 -0151
|
|
Correspondent Contact |
Donna Marshall |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 06/22/2018 |
Decision Date | 09/28/2018 |
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
|
|
|