Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K112034 |
Device Name |
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES |
Applicant |
CAREFUSION 209, INC. |
1850 Deming Way |
Middleton,
WI
53562
|
|
Applicant Contact |
GLEN HERMANSON |
Correspondent |
CAREFUSION 209, INC. |
1850 Deming Way |
Middleton,
WI
53562
|
|
Correspondent Contact |
GLEN HERMANSON |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 07/15/2011 |
Decision Date | 08/12/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|