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K Number
K971517
Device Name
SILICONE PUTTY EAR PLUGS
Manufacturer
BENTEC MEDICAL, INC.
Date Cleared
1997-06-02

(38 days)

Product Code
EWD
Regulation Number
N/A
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Silicone Putty Ear Plugs are used to block water from entering the ear canal.

Device Description

Silicone Putty Ear Plugs

AI/ML Overview

This document is a 510(k) clearance letter for "Silicone Putty Ear Plugs" (K071517). It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based solely on the provided text. The letter is a regulatory approval document, not a scientific study report.

N/A