Requirements Contents and Options : The 510k Submission

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GlobalCompliance Panel

GlobalCompliance Panel

Күн бұрын

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@zul.cenaheyn
@zul.cenaheyn 3 ай бұрын
Is 510k documents needed for ultrasonic dental tartar removal machine?
@slz1119
@slz1119 2 ай бұрын
I think you should check 21 CFR to identify if it is class I or class 2 , most class 1 is 510k exempt.
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