Device Classification Name |
Orthosis, Cranial
|
510(k) Number |
K001167 |
Device Name |
OPI BAND |
Applicant |
ORTHOMERICA PRODUCTS, INC. |
1001 PENNSYLVANIA AVE. NW. |
6TH FLOOR |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
WILLIAM H.E. VON OEHSEN |
Correspondent |
ORTHOMERICA PRODUCTS, INC. |
1001 PENNSYLVANIA AVE. NW. |
6TH FLOOR |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
WILLIAM H.E. VON OEHSEN |
Regulation Number | 882.5970
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 07/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|