Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K981081 |
Device Name |
BRIGHTSTAR |
Applicant |
HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Applicant Contact |
WILLIAM D JORDAN |
Correspondent |
HILL-ROM, INC. |
1069 STATE ROUTE 46 EAST |
BATESVILLE,
IN
47006
|
|
Correspondent Contact |
WILLIAM D JORDAN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/24/1998 |
Decision Date | 04/29/1998 |
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
|
|
|