Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K212380 |
Device Name |
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture |
Applicant |
Ethicon, Inc. |
1000 Route 202 |
Raritan,
NJ
08869
|
|
Applicant Contact |
Marife Sevek |
Correspondent |
Ethicon, Inc. |
1000 Route 202 |
Raritan,
NJ
08869
|
|
Correspondent Contact |
Marife Sevek |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 08/02/2021 |
Decision Date | 02/22/2022 |
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
|
|
|