Device Classification Name |
polymer patient examination glove |
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510(k) Number | K122465 | ||||
Device Name | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK | ||||
Applicant |
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Applicant Contact | s.n. hari | ||||
Correspondent |
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Correspodent Contact | s.n. hari | ||||
Regulation Number | 880.6250 | ||||
Classification Product Code |
|
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Date Received | 08/13/2012 | ||||
Decision Date | 10/16/2012 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
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statement |
statement |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |