510(k) K072334
K072334 is an FDA 510(k) premarket notification submitted by Sialo Technology, Ltd. for the device "SIALO DRAIN". The FDA issued a decision of Substantially Equivalent on July 18, 2008. The device falls under product code OAJ (Catheter, Drainage, Intraoral/Extraoral), a Class I device regulated under 21 CFR 878.4200. Sialo Technology, Ltd. has at least 3 other 510(k) clearances on record.
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