Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K932299 |
Device Name |
ELECTRO-MESH |
Applicant |
PRIZM MEDICAL, INC. |
3030 BUSINESS PARK DR. |
SUITE C |
NORCROSS,
GA
30071
|
|
Applicant Contact |
JAMES JOHNSON |
Correspondent |
PRIZM MEDICAL, INC. |
3030 BUSINESS PARK DR. |
SUITE C |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
JAMES JOHNSON |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 05/11/1993 |
Decision Date | 07/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|