# FDA 483 - Argentum Medical, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/argentum-medical-llc/d7662dd5-794f-4f18-9b20-17b1fa86a067

> FDA 483 for Argentum Medical, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argentum Medical, LLC
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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: https://www.keypedia.com/companies/argentum-medical-llc/f89e6a26-5280-4fe3-b871-3284cc42d66f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4