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FDA 510(k), K153678, PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
FDA 510(k), K153678, PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
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510(K) Number: K153678
Device Name: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
Manufacturer: PERMEADERM, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 12/21/2015
Decision Date: 08/08/2016
Regulation Medical Specialty:
Device Name: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
Manufacturer: PERMEADERM, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 12/21/2015
Decision Date: 08/08/2016
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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