BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER

    K Number: K974190 · Decision Nov 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    7
    Review Days
    15

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    Basic Information

    Device Name
    CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
    K Number
    K974190
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Products & Services, Inc.
    Date Received
    November 4, 1997
    Decision Date
    November 19, 1997
    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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    Other Clearances by Consolidated Products & Services, Inc.

    K Number Device Name
    K930759 CP & S STERILE BURN SHEET
    K890551 URINARY DRAINAGE UNIT
    K890550 CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
    K890552 CP&S GAVAGE CONSTAINER, DISPOSABLE
    K890553 CP&S DISPOSABLE INSTANT COLD COMPRESS
    K890554 CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS