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510(k) Data Aggregation
K Number
K023737Device Name
INJECTOR
Manufacturer
ANTON MEYER & CO. LTD.
Date Cleared
2003-07-14
(249 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
**ANTON MEYER **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
Device Description
The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens.
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