Argentum Medical, LLC

FDA 483 - Argentum Medical, LLC

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Record Details

This document is an FDA AI-HOLD letter issued to Argentum Medical, LLC concerning their 510(k) premarket notification for the Silverlon Antimicrobial Wound Contact Negative Pressure Dressing. The FDA was unable to determine substantial equivalence based on the initial submission and requested further information to complete the review process.

Company: Argentum Medical, LLC
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations

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ID · d7662dd5-794f-4f18-9b20-17b1fa86a067