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

    BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP

    K Number: K993871 · Decision Apr 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    63
    Review Days
    158

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    Basic Information

    Device Name
    BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
    K Number
    K993871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allegiance Healthcare Corp.
    Date Received
    November 15, 1999
    Decision Date
    April 21, 2000
    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 Allegiance Healthcare Corp.

    K Number Device Name
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    K024120 MODIFICATION TO TEMNO BIOPSY NEEDLES
    K024292 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
    K024102 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
    K023425 DRAPES WITH ABSORBENT REINFORCEMENT
    K022765 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023170 NITRILE POWDER-FREE EXAMINATION GLOVES
    K023167 BREATHABLE SURGICAL GOWN
    K012931 GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
    Search all 63 clearances from Allegiance Healthcare Corp. →