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510(k) Data Aggregation

    K Number
    K033381
    Device Name
    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2004-01-27

    (97 days)

    Product Code
    MED
    Regulation Number
    880.6885
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT,

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

    The DisChem™ Chemical Proportioning & Dispensing System, Aquarius model, for use exclusively with Cetlycide-G concentrate and diluent packaged specifically for the DisChem™ system, is intended for dispensing the Cetylcide-G use solution.

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) clearance letter for the DisChem™ Chemical Proportioning and Dispensing System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It states that the device can be marketed subject to general controls and other applicable regulations.

    Therefore, I cannot provide the requested information based on the provided input. The prompt specifically asks about performance studies and acceptance criteria, none of which are detailed in this regulatory clearance letter.

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