Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K143386 |
Device Name |
Progrip Laparoscopic Self-Fixating Mesh |
Applicant |
SOFRADIM PRODUCTION |
116 AVENUE DU FORMANS |
TREVOUX,
FR
01600
|
|
Applicant Contact |
Eric Jague |
Correspondent |
Surgical Devices, a global business unit of Covidien |
60 Middleton Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Mary Mellows |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/26/2014 |
Decision Date | 03/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|