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

    DEFEND SELF-SEALING STERILIZATION POUCH

    K Number: K932056 · Decision Jul 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    7
    Review Days
    441

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    Basic Information

    Device Name
    DEFEND SELF-SEALING STERILIZATION POUCH
    K Number
    K932056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carl Parker Associates, Inc.
    Date Received
    April 28, 1993
    Decision Date
    July 13, 1994
    Product Code
    KCT
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Carl Parker Associates, Inc.

    K Number Device Name
    K971130 DEFEND FLUID RESISTANT PLEATED MASK
    K962654 COMPLEAT SURGICAL MASK
    K891308 STERILE SURGICAL GLOVES
    K891257 DEFEND LATEX EXAMINATION GLOVES
    K891157 DEFEND LATEX EXAMINATION GLOVES
    K871558 DENTAL FACE MASKS, POLYESTER