Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K781887 |
Device Name |
9100 DAYSTAR AND 9110 ORBITER PACKAGE |
Applicant |
CASTLE CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CASTLE CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/07/1978 |
Decision Date | 12/12/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|