Device Classification Name |
Methyl Methacrylate For Cranioplasty
|
510(k) Number |
K991398 |
Device Name |
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT |
Applicant |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
KRISTYN R KELLEY |
Correspondent |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
KRISTYN R KELLEY |
Regulation Number | 882.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/1999 |
Decision Date | 09/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|