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510(k) Data Aggregation
K Number
K991206Device Name
BONASSE CONTACT LENS CASE
Manufacturer
BONASSE ENT. CO., LTD.
Date Cleared
2000-06-06
(424 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
BONASSE ENT. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.
Device Description
The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles include a lens basket used for holding the lens during storage.
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