Device Classification Name |
orthosis, limb brace
|
510(k) Number |
K821582 |
Device Name |
WARM'N FORM SPORTS SUPPORTS |
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 | 890.3475
|
Classification Product Code |
|
Date Received | 05/28/1982 |
Decision Date | 06/10/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|