Device Classification Name |
patient examination glove, specialty |
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---|---|---|---|---|
510(k) Number | K033789 | |||
Device Name | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING | |||
Applicant |
|
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Applicant Contact | erica sethi | |||
Correspondent |
|
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Correspodent Contact | erica sethi | |||
Regulation Number | 880.6250 | |||
Classification Product Code |
|
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Date Received | 12/04/2003 | |||
Decision Date | 05/07/2004 | |||
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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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |