Posted 16 Days Ago Job ID: 1582445 1 quotes received

fda 501 (k)

Fixed Price or Hourly W9 Required for U.S.
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  Send before: October 07, 2019

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i am the manufacturer of a custom scoliosis (spinal) brace. It is a class 1 device that is exempt from needing FDA approval in the US. However I am negotiating with a Chinese company to market the brace in China and they are asking for a 501 (k) certificate. This is not something I thought I  ... Show more
Gez B United States