Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K061037 |
Device Name |
PDS PLUS ANTIBACTERIAL SUTURE |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O.BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
BYRAN A LISA |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O.BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
BYRAN A LISA |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 04/14/2006 |
Decision Date | 07/14/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|