
Gn Danavox, Inc.
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133 SERIES BTE is an FDA 510(k)-cleared medical device (K905679) manufactured by Gn Danavox, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 27, 1991. Regulation: 8.

Ansell
SKU MSC846624

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McKesson
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SKU VM-1270031