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510(k) Data Aggregation
K Number
K110116Device Name
XEROS DRY MOUTH PUMP
Manufacturer
Date Cleared
2011-04-08
(84 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LORIN TECHNOLOGIES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief
Device Description
The XEROS Dry Mouth Pump is a microprocessor driven device which releases small amounts of water for a user-set duration at user-set intervals. It includes a rechargeable battery, water container, pump, and pump controller. The mouthpiece is a small comfortable fitting sponge attached to 1/8" tubing. All components of the XEROS Dry Mouth Pump are placed within a waist pack. It can be worn around the waist, on the shoulder, or placed on the nightstand for example.
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