Device Classification Name |
polymer patient examination glove |
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---|---|---|---|---|
510(k) Number | K081027 | |||
Device Name | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) | |||
Applicant |
|
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Applicant Contact | richard w wolfe | |||
Correspondent |
|
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Correspodent Contact | richard w wolfe | |||
Regulation Number | 880.6250 | |||
Classification Product Code |
|
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Date Received | 04/10/2008 | |||
Decision Date | 06/30/2008 | |||
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 |
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Type | Abbreviated | |||
Reviewed by Third Party | No | |||
Combination Product |
No |