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510(k) Data Aggregation

K Number

Device Name

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

Manufacturer

Date Cleared

2000-05-08

(90 days)

Product Code

Regulation Number

Type

Panel

Ophthalmic (OP)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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