Device Classification Name |
Component, Traction, Invasive
|
510(k) Number |
K822780 |
Device Name |
CERVICAL BRACE |
Applicant |
JEROME MEDICAL |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
JEROME MEDICAL |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/14/1982 |
Decision Date | 10/06/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|