Answer:A submitter of a premarket notification submission (510(k)) must demonstrate to the Food and Drug Administration (FDA) that the “new device” is “substantially equivalent” (SE) to a legally marketed predicate device. This guidance is intended to help 510(k) submitters demonstrate substantial equivalence. This guidance does not add new regulatory requirements for submitters, it does not change the 510(k) premarket review standard nor does it create extra or new burdens on what has traditionally been submitted in 510(k)s. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. Furthermore, this document is intended to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate device.
<span>You can bolt it to wall studs.</span>
Answer:
Explanation:
The phenotypes of snapdragons of F1 generation had pink flowers only.
Explanation:
The crossing of snapdragon with red flowers and white flowers as well led to the production of F1 offspring of hybrid quality having pink flowers only. This F1 phenotype under goes pollination and results in F2 phenotype with a ratio of 1 red, 1 white and 2 pink flower.
This is incomplete dominance as the phenotypes of parental plant, as in the white and red flowered plant reappear in the F2 generation.
Answer: any virus should be classified by or what it is
Explanation:
Answer:
If you want to lose one kg of your weight, you need to create calorie deficit of 7,700. So if you want to lose one kg per week, you need to create approximately 1,000 calorie deficit every day. If you create 1,000 calorie deficit every day, you will lose one kg of your weight in seven-eight days
