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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER

Manufacturer

MICRA INSTRUMENTS

Date Cleared

2001-10-22

(168 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)

Manufacturer

MICRA INSTRUMENTS LTD.

Date Cleared

1998-12-22

(235 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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