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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

COOL-TEC ELECTRODES

Manufacturer

SEEDLING ENTERPRISES. LLC.

Date Cleared

2000-12-08

(87 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

COOL-TEC ELECTRODES

Manufacturer

SEEDLING ENTERPRISES. LLC.

Date Cleared

2000-07-19

(43 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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