Device Classification Name |
system, x-ray, stationary |
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---|---|---|---|---|
510(k) Number | K110828 | |||
Device Name | DDRELEMENT | |||
Applicant |
|
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Applicant Contact | john monahan | |||
Correspondent |
|
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Correspodent Contact | john monahan | |||
Regulation Number | 892.1680 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 03/24/2011 | |||
Decision Date | 08/23/2011 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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statement |
statement |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |