Device Classification Name |
amplifier, physiological signal
|
510(k) Number |
K051852 |
Device Name |
SINGLE AMPLIFIER FOR BOTOX |
Applicant |
ALLERGAN, INC. |
2525 DUPONT DR. |
IRVINE,
CA
92612
|
|
Applicant Contact |
SUSAN O'BRIEN |
Correspondent |
ALLERGAN, INC. |
2525 DUPONT DR. |
IRVINE,
CA
92612
|
|
Correspondent Contact |
SUSAN O'BRIEN |
Regulation Number | 882.1835
|
Classification Product Code |
|
Date Received | 07/08/2005 |
Decision Date | 09/14/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|