UC知道希望英语高手翻译成中文
来源：百度知道 编辑：UC知道 时间：2024/07/03 04:49:37
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，有满意答案高分追加！（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
General Formatting Information
请把下面的翻译成英文，有满意答案高分追加！（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
晕死！机器翻译还有什么不明白的？不明白继续翻啊，翻到明白不就得了？
一个510(k)格式可能在部分,页码编号、含有一定数量的必需元素,包括:
-封面页或封面信,
(表的内容,
描述的装置,-
在设备规格、-information
-labeling,
当需要时,-testing数据,
用一个谓词装置——比较(s),而且,如果适用的话,信息在杀菌,
-computerized方面,
对设备以-standards,
-manufacturing信息,
8.5英寸-paper大小应由11英寸,
纸应该3-hole左边,穿孔
在左边边缘应1.5英寸。
安装一个510(k)。
一个510(k)应放在一个临时粘结剂。食品药物管理局(FDA)或三分之一在收到申请审查聚会将从绑定在它被提交,3-hole冲床左边边缘,并把510(k)在一个3-ring夹克的审核。
这是很重要的,并标示页码都没有正确的应用。永远绑如果页面都被FDA在审查过程,来复制为例,这将帮助那些评论员将页面回到正确的顺序。
三份510(k)应提交给第三方,申请人应保留一个额外的副本。两个副本都交给FDA和保留由第三方。
一封批准后方能生效(当适用第三次)提交文件的内容,讨论了代表你也必须提交伴随提交。
特定的格式,一个510(k)
协助生产建设510(k),美国食品及药物管理局已经产生许多指导文件。最重要的是你检查数据库存在的指南。
有些地方不是很明白……所以就用英文替代了