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FDA 510(k), K143335, Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
FDA 510(k), K143335, Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
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$149.00 USD
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$149.00 USD
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510(K) Number: K143335
Device Name: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Manufacturer: Roosin Medical Devices Co., Ltd
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 11/20/2014
Decision Date: 06/01/2015
Regulation Medical Specialty:
Device Name: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Manufacturer: Roosin Medical Devices Co., Ltd
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 11/20/2014
Decision Date: 06/01/2015
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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