Gyrus Ent LLC
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
SKU K033554UPC ETB
In Stock
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IIFDA 510(k) Cleared (K033554)
1
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Gyrus Ent LLC
Free shipping on orders over $99 · 30-day returns
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS is an FDA 510(k)-cleared medical device (K033554) manufactured by Gyrus Ent LLC. 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 November 23, 2003. Regulation: 8.
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