Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K080298 |
Device Name |
DERMABIOSAFE |
Applicant |
COMPLETE PRODUCT RESOURCES |
92 ARGONAUT # 200 |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
JOHN WALSH |
Correspondent |
COMPLETE PRODUCT RESOURCES |
92 ARGONAUT # 200 |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
JOHN WALSH |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 02/05/2008 |
Decision Date | 08/05/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|