Device Classification Name |
Headrest, Neurosurgical
|
510(k) Number |
K822169 |
Device Name |
SURGICAL HEAD SUPPORT |
Applicant |
KELLEHER CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KELLEHER CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.4440 |
Classification Product Code |
|
Date Received | 07/23/1982 |
Decision Date | 08/20/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|