Device Classification Name |
vinyl patient examination glove |
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---|---|---|---|---|
510(k) Number | K992100 | |||
Device Name | PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED | |||
Applicant |
|
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Applicant Contact | danny wang | |||
Correspondent |
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Correspodent Contact | danny wang | |||
Regulation Number | 880.6250 | |||
Classification Product Code |
|
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Date Received | 06/21/1999 | |||
Decision Date | 07/29/1999 | |||
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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statement |
statement |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |