Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K153611 |
Device Name |
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device |
Applicant |
Ethicon, LLC |
475 C Street |
Los Frailes Industrial Park, Suite 401,
PR
00969
|
|
Applicant Contact |
Marjorie Medina |
Correspondent |
Ethicon Endo-Surgery, Inc |
4545 Creek Road |
Cincinnati,
OH
45242
|
|
Correspondent Contact |
Rubina Dosani |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/17/2015 |
Decision Date | 06/03/2016 |
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
|
|
|