Device Classification Name |
vinyl patient examination glove |
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---|---|---|---|---|---|
510(k) Number | K992205 | ||||
Device Name | PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES | ||||
Applicant |
|
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Applicant Contact | susan d goldstein-falk | ||||
Correspondent |
|
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Correspodent Contact | susan d goldstein-falk | ||||
Regulation Number | 880.6250 | ||||
Classification Product Code |
|
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Date Received | 06/30/1999 | ||||
Decision Date | 07/23/1999 | ||||
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 | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |