Device Classification Name |
stimulator, spinal-cord, implanted (pain relief) |
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---|---|---|---|---|
510(k) Number | K033429 | |||
Device Name | LAMITRODE SPINAL CORD STIMULATION LEADS | |||
Applicant |
|
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Applicant Contact | danielle alarcon | |||
Correspondent |
|
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Correspodent Contact | danielle alarcon | |||
Regulation Number | 882.5880 | |||
Classification Product Code |
|
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Date Received | 10/28/2003 | |||
Decision Date | 12/04/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Neurology |
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510k Review Panel |
Neurology |
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statement |
statement |
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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |