Snake Bite Suction Kit
Who Makes This Device Type in China?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Anhui, Guangdong and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Planet (Anhui) International Co., Ltd. Anhui
- Planet (Anhui) Medical Products Co., Ltd. Anhui, contract manufacturer
- Planet(Shanghai) International Co., Ltd. Shanghai
What Is This Device?
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
How Is KYP Classified?
Snake Bite Suction Kit is FDA product code KYP, Class 1, 21 CFR 880.5740.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.