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Email alert just went out regarding their post

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luke5516   Monday, 06/17/19 03:41:44 PM
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Email alert just went out regarding their post op 510k. They are predicting an answer in 1-2 weeks. FDA asked for some statistical clarification on 6/14 and the company submitted their answer today. This is apparently the second follow up question and second response by BIEL.

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