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510(k) Data Aggregation
K Number
DEN140022Device Name
GLAUCOMA COMPANION
Manufacturer
Date Cleared
2016-04-20
(642 days)
Product Code
Regulation Number
886.5838Why did this record match?
Applicant Name (Manufacturer) :
INNOVATEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.
Device Description
The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge. The fastening bands are made from flame-retardant nylon hook and loop fabric. The frame width, nose bridge width, and nose pad shape of the subject device may be adjusted. The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath. There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.
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