Device Classification Name |
lamp, surgical
|
510(k) Number |
K100884 |
Device Name |
STRYKER KNIFELIGHT |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
AVITAL MERL-MARGULIES |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
AVITAL MERL-MARGULIES |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/30/2010 |
Decision Date | 06/25/2010 |
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
|
|
|