510(k) K072334

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 18, 2008

Date Received

August 20, 2007

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Catheter, Drainage, Intraoral/Extraoral

Device Class

Class I

Regulation Number

878.4200

Review Panel

DE

Submission Type

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