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K Number
K972923
Device Name
SUPER SILIPLUGS EAR PLUGS
Manufacturer
INTERVIEW MEDICAL TECHNOLOGY CORP.
Date Cleared
1997-10-27

(80 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

Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.

Device Description

Super SiliPlugs™ Ear Plugs

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K972923 for "Super SiliPlugs™ Ear Plugs" does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.

The document is a clearance letter from the FDA, stating that the device is "substantially equivalent for the indications for use" to devices marketed prior to May 28, 1976. This indicates that the device's acceptable performance is based on its similarity to existing legally marketed devices, rather than a specific set of new performance metrics and a study to achieve them.

Therefore, I cannot provide the requested table or the detailed study information because it is not present in the given text. The clearance process for this type of device, particularly in 1997, often relied on substantial equivalence demonstration rather than extensive novel performance studies.

N/A