BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CARERITE FACE MASK

    K Number: K873705 · Decision Oct 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    CARERITE FACE MASK
    K Number
    K873705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cost Rite Health Products, Inc.
    Date Received
    September 14, 1987
    Decision Date
    October 5, 1987
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    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
    FXX Mask, Surgical

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    Other Clearances by Cost Rite Health Products, Inc.

    K Number Device Name
    K891141 CARERITE FACE MASK
    K890667 RUBBER DAM
    K871798 FILM AND PAPER COMBINATION STERILIZING BAG
    K871736 CARERITE BIOPACK GINGIVAL RETRACTION CORD
    K870147 CARERITE & COST RITE NYLON STERILIZATION FILM
    K870906 CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500