Device Classification Name |
latex patient examination glove |
|||
---|---|---|---|---|
510(k) Number | K992428 | |||
Device Name | ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE | |||
Applicant |
|
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Applicant Contact | thomas n tillotson | |||
Regulation Number | 880.6250 | |||
Classification Product Code |
|
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Date Received | 07/21/1999 | |||
Decision Date | 08/09/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
|||
510k Review Panel |
General Hospital |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | Yes | |||
Combination Product |
No |