Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K051774 |
Device Name |
MBCP |
Applicant |
BIOMATLANTE |
5, RUE EDOUARD BELIN |
VIGNEUX DE BRETAGNE,
FR
44360
|
|
Applicant Contact |
MYRIAM VINCENT |
Correspondent |
BIOMATLANTE |
5, RUE EDOUARD BELIN |
VIGNEUX DE BRETAGNE,
FR
44360
|
|
Correspondent Contact |
MYRIAM VINCENT |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 07/01/2005 |
Decision Date | 01/20/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|