OAJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Catheter, Drainage, Intraoral/Extraoral

Device class

Class I (low risk)

Regulation

21 CFR 878.4200

Medical specialty

General, Plastic Surgery

FDA definition

To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones

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