Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K142822 |
Device Name |
PLIASURE Polyglycolide Synthetic Absorbable Suture |
Applicant |
ETHICON, Inc. |
Rt. 22 West, P.O. Box 151 |
Somerville,
NJ
08876
|
|
Applicant Contact |
Susan Lin |
Correspondent |
ETHICON, Inc. |
Rt. 22 West, P.O. Box 151 |
Somerville,
NJ
08876
|
|
Correspondent Contact |
Susan Lin |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 09/30/2014 |
Decision Date | 03/26/2015 |
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 |
No
|
|
|