Device Classification Name |
cord, retraction
|
510(k) Number |
K150423 |
Device Name |
EXPAZEN |
Applicant |
PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) |
17 AVENUE GUSTAVE EIFFEL |
ZI DU PHARE |
MERIGNAC,
FR
33708
|
|
Applicant Contact |
GENEVIEVE DE VILLEDON |
Correspondent |
ACTEON, INC. |
124 GAITHER DR., SUITE 140 |
MOUNT LAUREL,
NJ
08054
|
|
Correspondent Contact |
RICK ROSATI |
Classification Product Code |
|
Date Received | 02/19/2015 |
Decision Date | 07/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|