Device Classification Name |
motor, drill, pneumatic
|
510(k) Number |
K150801 |
Device Name |
Stryker Maestro Air Motors |
Applicant |
STRYKER CORPORATION |
4100 E. MILHAM AVENUE |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
DEVAL PATEL |
Correspondent |
STRYKER CORPORATION |
4100 E. MILHAM AVENUE |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
DEVAL PATEL |
Regulation Number | 882.4370
|
Classification Product Code |
|
Date Received | 03/26/2015 |
Decision Date | 05/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|