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Re: Baxy post# 31645

Sunday, 09/10/2017 4:57:58 PM

Sunday, September 10, 2017 4:57:58 PM

Post# of 37663
Hey Baxy,
510k doesnt require process validation. MFST can get FDA approval and that's a huge milestone, since then they can share their FDA approval with a manufacturing company and receive royalties. For me, it is more important to have the approval than make sure it is ready for manufacturing...

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