BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SAFE-T-SEAL

    K Number: K953829 · Decision Nov 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    SAFE-T-SEAL
    K Number
    K953829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gs Medical Packaging, Inc.
    Date Received
    August 16, 1995
    Decision Date
    November 9, 1995
    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 Gs Medical Packaging, Inc.

    K Number Device Name
    K141412 STERILUCENT SELF-SEAL STERILIZATION POUCH