BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    INSTANT HOT OR COLD DISPOSABLE PACK

    K Number: K935569 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    1
    Review Days
    109

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    Basic Information

    Device Name
    INSTANT HOT OR COLD DISPOSABLE PACK
    K Number
    K935569
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cryopak Industries, Inc.
    Date Received
    November 18, 1993
    Decision Date
    March 7, 1994
    Product Code
    IMD
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMD Pack, Hot Or Cold, Disposable

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