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510(k) Data Aggregation

K Number

Device Name

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

Manufacturer

PROMEDICAL PRODUCTS CO., LTD.

Date Cleared

2009-05-27

(41 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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