BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINI MICK APPLICATOR

    K Number: K802032 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    43
    Review Days
    62

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    Basic Information

    Device Name
    MINI MICK APPLICATOR
    K Number
    K802032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3800
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Mick Radio-Nuclear Instruments, Inc.
    Date Received
    August 22, 1980
    Decision Date
    October 23, 1980
    Product Code
    JWJ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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    Other Clearances by Mick Radio-Nuclear Instruments, Inc.

    K Number Device Name
    K230155 Mick Valencia Applicator Set
    K200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
    K150979 CT/MR Compatible M.A.C. Interstitial GYN Template
    K142597 Vienna System
    K122840 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
    K063382 HDR CT COMPATIBLE SPLIT RING APPLICATOR
    K063381 CT COMPATIBLE F/S/D APPLICATORS
    K052351 HDR IORT SHIELDED APPLICATOR
    K051423 MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
    K040704 MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
    Search all 43 clearances from Mick Radio-Nuclear Instruments, Inc. →