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510(k) Data Aggregation
K Number
K030471Device Name
OPHTEC ENCLAVATION NEEDLE
Manufacturer
Date Cleared
2003-04-17
(64 days)
Regulation Number
886.4350Why did this record match?
Applicant Name (Manufacturer) :
OPHTEC USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.
Device Description
Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configuration so as to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The instrument has an acrylic handle and one needle at each end. Each end is uniquely designed to create a right-hand end and a left-hand end to aid the surgeon during the procedure.
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K Number
K011498Device Name
EASY CONTROL MICRO INSERTER, MODEL ON385
Manufacturer
Date Cleared
2001-07-09
(55 days)
Product Code
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
OPHTEC USA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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