
Bernafon-Maico, Inc.
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DUALINE 100 BTE is an FDA 510(k)-cleared medical device (K973948) manufactured by Bernafon-Maico, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 27, 1997. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031