Device Classification Name |
latex patient examination glove |
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---|---|---|---|---|---|
510(k) Number | K991677 | ||||
Device Name | REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) | ||||
Applicant |
|
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Applicant Contact | bradley l pugh | ||||
Correspondent |
|
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Correspodent Contact | bradley l pugh | ||||
Regulation Number | 880.6250 | ||||
Classification Product Code |
|
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Date Received | 05/17/1999 | ||||
Decision Date | 04/12/2000 | ||||
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 |