Device Classification Name |
system, image processing, radiological |
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---|---|---|---|---|---|
510(k) Number | K021236 | ||||
Device Name | SURGERY AND ACCESSORIES | ||||
Original Applicant |
|
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Original Contact | scott pease | ||||
Regulation Number | 892.2050 | ||||
Classification Product Code |
|
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Date Received | 04/18/2002 | ||||
Decision Date | 07/17/2002 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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summary |
summary |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |