Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K111816 |
Device Name |
EQUIMATRIX |
Applicant |
LUITPOLD PHARMACEUTICALS, INC. |
ONE LUITPOLD DR. |
P.O. BOX 9001 |
SHIRLEY,
NY
11967
|
|
Applicant Contact |
MARSHA SIMON |
Correspondent |
LUITPOLD PHARMACEUTICALS, INC. |
ONE LUITPOLD DR. |
P.O. BOX 9001 |
SHIRLEY,
NY
11967
|
|
Correspondent Contact |
MARSHA SIMON |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 06/27/2011 |
Decision Date | 09/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|