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510(k) Data Aggregation
K Number
K110166Device Name
CLEARCUT S SAFETY KNIFE
Manufacturer
ALCON RESEARCH, LTD.
Date Cleared
2011-05-20
(120 days)
Product Code
HNN
Regulation Number
886.4350Why did this record match?
Product Code :
HNN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.
Device Description
The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.
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