Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K001724 |
Device Name |
STIMULAN -CALCIUM SULFATE BONE VOID FILTER |
Applicant |
BIOCOMPOSITES LTD. |
ETRUSCAN ST. |
ETRURIA |
STOKE ON TRENT, STAFFORDSHIRE,
GB
ST1 5PQ
|
|
Applicant Contact |
STEPHEN BRATT |
Correspondent |
BIOCOMPOSITES LTD. |
ETRUSCAN ST. |
ETRURIA |
STOKE ON TRENT, STAFFORDSHIRE,
GB
ST1 5PQ
|
|
Correspondent Contact |
STEPHEN BRATT |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 06/06/2000 |
Decision Date | 08/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|