Device Classification Name |
electrosurgical, cutting & coagulation & accessories |
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---|---|---|---|---|
510(k) Number | K013680 | |||
Device Name | CARBODISSECTING ENDOSCOPE | |||
Original Applicant |
|
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Original Contact | debbie iampietro | |||
Regulation Number | 878.4400 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 11/07/2001 | |||
Decision Date | 03/04/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
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510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |