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

    SOFTIC 49

    K Number: K821230 · Decision May 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    29
    Review Days
    31

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    Basic Information

    Device Name
    SOFTIC 49
    K Number
    K821230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    April 27, 1982
    Decision Date
    May 28, 1982
    Product Code
    EBI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by The Healthcare Group Laboratories, Inc.

    K Number Device Name
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    K842170 EMPTY SOLUTION TRANSFER CONTAINER
    K842091 DISPOS. ACU-CUT SOFT TISSUE BIOPSY
    K840742 RIGHT ATRIAL CATHETER
    K830299 SOLUTION TRANSFER CONTAINER
    K822307 ADHESIVE SPRAY #4050-4060
    K822059 SHOW'RBAG
    K821480 RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
    K821162 ADHESIVE REMOVER
    K821172 EXTERNAL FEMALE URINARY INCONTINENCE
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