Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K073164 |
Device Name |
IVS TUNNELLER DEVICES |
Applicant |
COVIDIEN UK MANUFACTURING LTD |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
SHARON ALEXANDER |
Correspondent |
COVIDIEN UK MANUFACTURING LTD |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
SHARON ALEXANDER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/09/2007 |
Decision Date | 03/05/2008 |
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
|