510(k)???? - ???????????

510(k)???????(Premarket Notification, PMN)????FDA???,????????????????????????????????????????????????????????? ??????,??????????????,??????FDA?????????510(k)????:

1. ???510(k)
2. ???510(k)
3. ???510(k)

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1. ?????????????
2. ??????????????
3. ??510(k)????
4. ???FDA??510(k)????
5. ???FDA?????
6. ???510(k)?????(????????????……)

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