Device Classification Name |
system,x-ray,extraoral source,digital |
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---|---|---|---|---|
510(k) Number | K010915 | |||
Device Name | CDMX | |||
Original Applicant |
|
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Original Contact | jay choi | |||
Regulation Number | 872.1800 | |||
Classification Product Code |
|
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Date Received | 03/27/2001 | |||
Decision Date | 05/21/2001 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Dental |
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510k Review Panel |
Radiology |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |