Device Classification Name |
massager, powered inflatable tube |
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---|---|---|---|---|---|
510(k) Number | K112441 | ||||
Device Name | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM | ||||
Applicant |
|
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Applicant Contact | daniel nam | ||||
Correspondent |
|
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Correspodent Contact | daniel nam | ||||
Regulation Number | 890.5650 | ||||
Classification Product Code |
|
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Date Received | 08/24/2011 | ||||
Decision Date | 01/17/2012 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Physical Medicine |
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510k Review Panel |
Neurology |
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summary |
summary |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |