| Device Classification Name |
electrode, needle, diagnostic electromyograph |
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|---|---|---|---|---|
| 510(k) Number | K111131 | |||
| Device Name | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | |||
| Applicant |
|
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| Applicant Contact | glen hermanson | |||
| Correspondent |
|
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| Correspodent Contact | glen hermanson | |||
| Regulation Number | 890.1385 | |||
| Classification Product Code |
|
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| Subsequent Product Code |
|
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| Date Received | 04/21/2011 | |||
| Decision Date | 06/17/2011 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Physical Medicine |
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| 510k Review Panel |
Neurology |
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| summary |
summary |
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| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |