Device Classification Name |
vinyl patient examination glove |
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---|---|---|---|---|
510(k) Number | K030484 | |||
Device Name | SYNTHETICARE POWDERED VINYL 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 | 02/14/2003 | |||
Decision Date | 03/06/2003 | |||
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 |