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

    POUCHES, GAS STERILIZATION

    K Number: K781925 · Decision Nov 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    7
    Review Days
    12

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    Basic Information

    Device Name
    POUCHES, GAS STERILIZATION
    K Number
    K781925
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medicare Industries, Inc.
    Date Received
    November 10, 1978
    Decision Date
    November 22, 1978
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRG Wrap, Sterilization

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    Other Clearances by Medicare Industries, Inc.

    K Number Device Name
    K894197 LATEX EXAMINATION GLOVES
    K891865 NIL (PATIENT EXAMINATION GLOVES - LATEX)
    K791434 SPONGE COUNTER BAGS
    K781980 RESPIRATORY THERAPY GAS POUCH
    K781981 DECONTAMINATION ITEMS BAG
    K781924 POUCHES AND TUBING, MEDI-SEAL