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510(k) Data Aggregation
K Number
K140352Device Name
VERAPLUG
Manufacturer
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
Date Cleared
2014-11-13
(274 days)
Product Code
LZU
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
Device Description
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
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