Device Classification Name |
Driver, Wire, And Bone Drill, Manual
|
510(k) Number |
K040369 |
Device Name |
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
Applicant |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
JEAN W SHEPPARD |
Correspondent |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
JEAN W SHEPPARD |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 02/13/2004 |
Decision Date | 04/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|