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510(k) Data Aggregation

K Number

Device Name

Manufacturer

POLLAK (INTL.), LTD.

Date Cleared

2000-04-27

(94 days)

Product Code

Regulation Number

Type

Panel

Obstetrics and Gynecology (OB)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

UMBICUT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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