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What is BCT Antimicrobial Dressing Summary about?

The document provides a 510(k) summary for the BCT Antimicrobial Dressing and BCT Silver Bandage. [1] The devices are intended to manage wounds and provide an antimicrobial barrier through the use of silver-coated activated carbon fiber cloth. [2] The substantial equivalence discussion compares the new devices to the legally marketed predicate device ACTISORB Silver 220 Antimicrobial Binding Dressing and finds the devices to have similar intended uses, technological characteristics, and safety and effectiv

Author

Oriana Garcia

Language

EN