
Ue Lifesciences, Inc.
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iBreastExam is an FDA 510(k)-cleared medical device (K190575) manufactured by Ue Lifesciences, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2019. Regulation: 8.

Ansell
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McKesson
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SKU VM-1270031