
Laurimed, LLC
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PolypVac Microdebrider (3.3mm and 4.0mm) is an FDA 510(k)-cleared medical device (K161101) manufactured by Laurimed, 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 June 21, 2016. Regulation: 8.

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McKesson
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SKU VM-1270031