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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, drainage, intraoral/extraoral
Regulation Description Introduction/drainage catheter and accessories.
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
Product CodeOAJ
Regulation Number 878.4200
Device Class 1

Device Problems
Device Operates Differently Than Expected 1
Total Device Problems 1