Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K943569 |
Device Name |
STRYKER TOTAL PERFORMANCE SYSTEM |
Applicant |
STRYKER CORP. |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
TAMMY LOUNDS |
Correspondent |
STRYKER CORP. |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
TAMMY LOUNDS |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 07/22/1994 |
Decision Date | 01/09/1995 |
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
|
|
|