Device Classification Name |
Stimulator, Spinal-Cord, Implanted (Pain Relief)
|
510(k) Number |
K921319 |
Device Name |
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 |
Applicant |
NEUROMED, INC. |
5000-A OAKES RD., SUITE A |
FT. LAUDERDALE,
FL
33314
|
|
Applicant Contact |
DEAN E CIPORKIN |
Correspondent |
NEUROMED, INC. |
5000-A OAKES RD., SUITE A |
FT. LAUDERDALE,
FL
33314
|
|
Correspondent Contact |
DEAN E CIPORKIN |
Regulation Number | 882.5880
|
Classification Product Code |
|
Date Received | 03/19/1992 |
Decision Date | 05/05/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|