Device Classification Name |
Lamp, Surgical
|
510(k) Number |
K981717 |
Device Name |
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR |
Applicant |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
NICOLE PETTY |
Correspondent |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
NICOLE PETTY |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 05/15/1998 |
Decision Date | 06/30/1998 |
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
|
|
|