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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)

Manufacturer

LAKE REGION MFG., INC.

Date Cleared

2000-12-06

(27 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

MODIFIED HYDROPHILIC COATED GUIDEWIRE

Manufacturer

LAKE REGION MFG., INC.

Date Cleared

2000-03-01

(58 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K092303,K124052,K133155

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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