Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K000348 |
Device Name |
COLORADO MICRODISSECTION NEEDLE |
Applicant |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
KRISTYN R KELLEY |
Correspondent |
STRYKER LEIBINGER |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
KRISTYN R KELLEY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/03/2000 |
Decision Date | 05/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|