Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K011381 |
Device Name |
HUMMER IV MICRODEBRIDER SYSTEM |
Applicant |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
ROBIN L ROWE |
Correspondent |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
ROBIN L ROWE |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 05/07/2001 |
Decision Date | 05/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|