
Entellus Medical, Inc.
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PassAssist LED Light Fiber is an FDA 510(k)-cleared medical device (K152435) manufactured by Entellus Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 19, 2015. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031