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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MONARCH II IOL DELIVERY SYSTEM

Manufacturer

ALCON RESEARCH, LTD.

Date Cleared

2001-01-05

(30 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K040837,K063155,K082871

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

MONARCH II IOL DELIVERY SYSTEM

Manufacturer

ALCON RESEARCH, LTD.

Date Cleared

2000-06-27

(78 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K022723,K063155,K112977

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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