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510(k) Data Aggregation

K Number

Device Name

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL

Manufacturer

DONGKUK TECHCO RUBBER INDUSTRIES

Date Cleared

2000-09-07

(63 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

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Device Name :

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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