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OAJ — Catheter, Drainage, Intraoral/Extraoral Class I

FDA Device Classification

FDA product code OAJ covers "Catheter, Drainage, Intraoral/Extraoral", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
OAJ
Device Class
Class I
Regulation Number
878.4200
Submission Type
Review Panel
DE
Medical Specialty
General, Plastic Surgery
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K072334sialo technologySIALO DRAINJuly 18, 2008

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