Blower, Powder, Ent

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu.

Huizhou Kaiyi Technology Co., Ltd. Guangdong
Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer

How Is KCL Classified?

Blower, Powder, Ent is FDA product code KCL, Class 1, 21 CFR 874.5220.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

Blower, Powder, Ent

BR Surgical, LLC

POLITZER air bag complete, w/ 4 tips & connecting nozzle

Blower, Powder, Ent

Kabierske Powder Blower SET

Catalogue number 465-400, listed by Sontec Instruments, Inc., United States, under Blower, Powder, Ent. 2 manufacturers in China are registered for this product code.

Blower, Powder, Ent

Dryswab

Dryswab, fine tip plastic, peel pouch rayon bud

Blower, Powder, Ent

Kabierske Powder Blower Cannula

Catalogue number 465-400F, listed by Sontec Instruments, Inc., United States, under Blower, Powder, Ent. 2 manufacturers in China are registered for this product code.

Blower, Powder, Ent