
Safkan, Inc.
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OtoSet- Ear Cleaning System is an FDA 510(k)-cleared medical device (K201877) manufactured by Safkan, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 4, 2020. Regulation: 8.

Ansell
SKU MSC846624

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McKesson
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Hollister
SKU VM-1270031