Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K183183 |
Device Name |
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture |
Applicant |
Ethicon, Inc. |
Route 22 West P.O. Box 151 |
Somerville,
NJ
08876
|
|
Applicant Contact |
Stephanie Saati |
Correspondent |
Ethicon, Inc. |
Route 22 West P.O. Box 151 |
Somerville,
NJ
08876
|
|
Correspondent Contact |
Stephanie Saati |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 06/27/2019 |
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
|
|
|