Device Classification Name |
system,x-ray,extraoral source,digital |
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---|---|---|---|---|---|
510(k) Number | K023292 | ||||
Device Name | APEX HRI DIGITAL RADIOGRAPHY SYSTEM | ||||
Original Applicant |
|
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Original Contact | michael a krugman | ||||
Regulation Number | 872.1800 | ||||
Classification Product Code |
|
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Date Received | 10/02/2002 | ||||
Decision Date | 12/13/2002 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Dental |
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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 |