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K Number
K020296
Device Name
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
Manufacturer
APOTHECARY PRODUCTS, INC.
Date Cleared
2002-06-25

(148 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

Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

Device Description

Adult Silicone Ear Plug

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device (Adult Silicone Ear Plugs). It does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to AI/algorithm performance.

Therefore, I cannot fulfill the request using the given input. The document is solely a regulatory approval for marketing the device, confirming its substantial equivalence to a predicate device.

N/A