Device Classification Name |
endoscopic central control unit |
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---|---|---|---|---|
510(k) Number | K111165 | |||
Device Name | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE | |||
Applicant |
|
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Applicant Contact | crystal hagan | |||
Correspondent |
|
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Correspodent Contact | crystal hagan | |||
Regulation Number | 876.1500 | |||
Classification Product Code |
|
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Date Received | 04/26/2011 | |||
Decision Date | 01/06/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Gastroenterology/Urology |
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510k Review Panel |
Gastroenterology/Urology |
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summary |
summary |
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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |