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510(k) Data Aggregation

    K Number
    K093266
    Device Name
    MAM COOLER
    Manufacturer
    MAM INTERNATIONAL AG
    Date Cleared
    2010-07-27

    (281 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAM INTERNATIONAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K092781
    Device Name
    MAM TWISTER
    Manufacturer
    MAM INTERNATIONAL AG
    Date Cleared
    2010-06-23

    (286 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAM INTERNATIONAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
    Device Description
    Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9
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