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

    CERTI COOL INSTANT COLD COMPRESS

    K Number: K960624 · Decision May 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    17
    Review Days
    83

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    Basic Information

    Device Name
    CERTI COOL INSTANT COLD COMPRESS
    K Number
    K960624
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Certified Safety Mfg., Inc.
    Date Received
    February 13, 1996
    Decision Date
    May 6, 1996
    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 Certified Safety Mfg., Inc.

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    K940249 CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
    K941311 FIRST AID/TRUMA KIT
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