Device Classification Name |
neurological stereotaxic instrument |
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---|---|---|---|---|---|
510(k) Number | K023949 | ||||
Device Name | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | ||||
Original Applicant |
|
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Original Contact | david m lee | ||||
Regulation Number | 882.4560 | ||||
Classification Product Code |
|
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Date Received | 11/27/2002 | ||||
Decision Date | 02/25/2003 | ||||
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 | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |