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FDA 510(k), K190819, Silicone PHMB Foam Wound Dressing
FDA 510(k), K190819, Silicone PHMB Foam Wound Dressing
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$149.00 USD
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510(K) Number: K190819
Device Name: Silicone PHMB Foam Wound Dressing
Manufacturer: Adam Gregory
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: 04/01/2019
Date Received: 07/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Silicone PHMB Foam Wound Dressing
Manufacturer: Adam Gregory
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: 04/01/2019
Date Received: 07/25/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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