English letters please help turn down on medical devices

I read your section 510(k) knowing that you intended to market the device, and we decided to refer to all of the devices above as being substantially equivalent to the devices that appeared in interstate commerce prior to the enactment of the Medical Devices Amendments you may therefore market under the General Control Provisions of the device.subject to the requirements of the Federal Food, Drug, and Cosmetic (Acts), General Control Act.

If you decive into two categories 2 (performance standards) or 3 can additionally control the current existence of major equipment atfecting regulations can be found in the U.S. Code of Federal Regulations. Title, Part 895.in 21 names, Food and Government Administration (FDA) has been established to publish further statements regarding your device in the Federal Register. Note: This response to Pleasa premarket notifies you of any obligation to submit, and does not affect, any health and safety practices you may have with respect to radiation control, or other federal laws or regulations of 1968.

This letter will immediately get you started on developing a proper description of your device. A U.S. Food and Drug Administration found substantial equivalence in the device pre-amendments device that results for your device and classified it

Allowing your device to be marketed does not mean that the Food and Drug Administration (FDA) approves your device, and therefore you may not promote or largely represent your device or its labeling to be approved by the FDA.