Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K060367 |
Device Name |
TENOLIG |
Applicant |
FOURNITURES HOSPITALIERES INDUSTRIE |
ZI DE KERNEVEZ-6 RUE NOBEL |
QUIMPER,
FR
29000
|
|
Applicant Contact |
CHRISTINE QUENDEZ |
Correspondent |
FOURNITURES HOSPITALIERES INDUSTRIE |
ZI DE KERNEVEZ-6 RUE NOBEL |
QUIMPER,
FR
29000
|
|
Correspondent Contact |
CHRISTINE QUENDEZ |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 02/13/2006 |
Decision Date | 08/09/2006 |
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 |
No
|
|
|