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510(k) Data Aggregation

K Number

Device Name

DIAMOND II VALVE

Manufacturer

PHOENIX BIOMEDICAL CORP.

Date Cleared

1999-05-19

(23 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

DIAMOND II VALVE

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

This device is intended as the principle pressure regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.

Device Description

Not Found

AI/ML Overview

I am sorry but this document does not contain the answer to your question. The document is a 510(k) premarket notification letter from the FDA regarding the "Diamond II Valve" and does not include details about acceptance criteria, device performance studies, or related information.

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