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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MODIFICATION TO: LOCATOR IMPLANT ANCHOR

Manufacturer

ZEST ANCHORS, INC.

Date Cleared

2007-12-03

(55 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K092594,K150295,K151789,K182228

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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