Search Results
Found 1 results
510(k) Data Aggregation
K Number
K072334Device Name
SIALO DRAIN
Manufacturer
SIALO TECHNOLOGY, LTD.
Date Cleared
2008-07-18
(333 days)
Product Code
OAJ
Regulation Number
878.4200Why did this record match?
Product Code :
OAJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.
The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.
Device Description
The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.
Ask a Question
Page 1 of 1