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510(k) Data Aggregation
K Number
K000127Manufacturer
Date Cleared
2000-04-12
(85 days)
Product Code
Regulation Number
886.5700Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
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Device Name :
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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