Device Classification Name |
Tong, Skull For Traction
|
510(k) Number |
K864746 |
Device Name |
BREMER HALO SYSTEM |
Applicant |
BREMER ORTHOPEDICS |
433 MARGARET ST. |
JACKSONVILLE,
FL
32204
|
|
Applicant Contact |
PAUL W BREMER |
Correspondent |
BREMER ORTHOPEDICS |
433 MARGARET ST. |
JACKSONVILLE,
FL
32204
|
|
Correspondent Contact |
PAUL W BREMER |
Regulation Number | 882.5960
|
Classification Product Code |
|
Date Received | 12/05/1986 |
Decision Date | 12/22/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|