Device Classification Name |
lamp, surgical
|
510(k) Number |
K961122 |
Device Name |
STRYKER KNIFELIGHT |
Applicant |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
DIANE DAVIS |
Correspondent |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
DIANE DAVIS |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/21/1996 |
Decision Date | 08/22/1996 |
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
|
|
|