Sofregen Medical
Silk Voice (SMI-04)
SKU K240919UPC MIX
In Stock
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IIFDA 510(k) Cleared (K240919)
1
Free shipping on orders over $99 · 30-day returns
Sofregen Medical
Free shipping on orders over $99 · 30-day returns
Silk Voice (SMI-04) is an FDA 510(k)-cleared medical device (K240919) manufactured by Sofregen Medical. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 2024. Regulation: 8.
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