Device Classification Name |
light, surgical, fiberoptic
|
510(k) Number |
K080367 |
Device Name |
ZIMMER MIS LIGHT |
Applicant |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Applicant Contact |
ELSA A LINKE |
Correspondent |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Correspondent Contact |
ELSA A LINKE |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 02/12/2008 |
Decision Date | 02/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|