Device Classification Name |
cement, ear, nose and throat
|
510(k) Number |
K060750 |
Device Name |
STRYKER INJECTABLE CEMENT |
Applicant |
STRYKER CMF |
750 TRADE CENTRE WAY |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
WADE T RUTKOSKIE |
Correspondent |
STRYKER CMF |
750 TRADE CENTRE WAY |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
WADE T RUTKOSKIE |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 03/21/2006 |
Decision Date | 04/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|