Device Classification Name |
dressing, wound, drug |
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---|---|---|---|---|---|
510(k) Number | K121819 | ||||
Device Name | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER | ||||
Applicant |
|
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Applicant Contact | christopher fredric | ||||
Correspondent |
|
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Correspodent Contact | christopher fredric | ||||
Classification Product Code |
|
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Date Received | 06/21/2012 | ||||
Decision Date | 08/13/2012 | ||||
Decision |
substantially equivalent (SESE) |
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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 |
Yes |