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510(k) Data Aggregation

    K Number
    K971757
    Device Name
    LOW PROFILE FEEDING SET ACCESSORY
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1997-11-07

    (178 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LOW PROFILE FEEDING SET ACCESSORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Low Profile Feeding Set Accessory" and its accompanying "Indications For Use Statement." It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Medical devices like this typically undergo laboratory testing and performance evaluations, but the details of such studies are not present in these FDA documents.

    Therefore, I cannot provide the requested information from the given input. The document is primarily an administrative letter confirming the device's substantial equivalence to a predicate device and its regulatory classification.

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