Device Classification Name |
bandage, liquid |
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---|---|---|---|---|
510(k) Number | K992032 | |||
Device Name | ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 | |||
Applicant |
|
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Applicant Contact | bruce gibbins | |||
Correspondent |
|
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Correspodent Contact | bruce gibbins | |||
Regulation Number | 880.5090 | |||
Classification Product Code |
|
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Date Received | 06/16/1999 | |||
Decision Date | 08/19/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |