483
Argentum Medical, LLCArgentum Medical, LLC – FDA 483
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
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ID · d7662dd5-794f-4f18-9b20-17b1fa86a067
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