英语翻译Before submitting the 510(k) for review,the following sh

英语翻译Before submitting the 510(k) for review,the following should be considered:General Formatting Information请把下面的翻译成英文,（太长了不好意思）A 510(k) may be formatted in sections,with page numbering,to contain a number of required elements including:-a Cover Sheet or Cover Letter,-a Table of Contents,-a description of the device,-information on device specifications,-labeling,-testing data when required,-a comparison with a predicate device(s),and,if applicable,information on sterilization,-computerized aspects,-standards to which the device adheres,-manufacturing information,-paper size should be 8.5 inches by 11 inches,paper should be 3-hole punched on the LEFT side,the margin on left should be 1.5 inches.Assembling a 510(k)A 510(k) should be put in a temporary binder.Upon receipt FDA or a third review party will take the application out of the binding in which it was submitted,3-hole punch the left margin,and put the 510(k) in a 3-ring "jacket" for review.It is important to have all pages numbered correctly and DO NOT permanently bind the application.If pages are removed by FDA during the review process,to be copied for example,this will help the reviewer put the pages back in the correct order.Three copies of the 510(k) should be submitted to a third party,and the applicant should retain an additional copy.Two copies are submitted to the FDA and one retained by the third party.A letter authorizing the third patry (when applicable) to submit the document and discuss the contents of the submission on your behalf must also accompany the submission.Particular Formatting of a 510(k)To assist the manufacturer in constructing a 510(k),the FDA has generated many guidance documents.It is important that you check the databases for the existence of a guidance document.去哪领奖？要不要先交钱在领奖？