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

    MAMMARY SIZER

    K Number: K982258 · Decision Sep 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    12
    Review Days
    74

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    Basic Information

    Device Name
    MAMMARY SIZER
    K Number
    K982258
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Specialty Surgical Products, Inc.
    Date Received
    June 26, 1998
    Decision Date
    September 8, 1998
    Product Code
    MRD
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRD Mammary Sizer

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    Other Clearances by Specialty Surgical Products, Inc.

    K Number Device Name
    K140383 ALLOX2 TISSUE EXPANDERS
    K984106 MAMMARY SIZER, MAMMARY PROTHESIS SIZER
    K983015 VIRILIS PENILE PROSTHESIS
    K982065 STERILE SILICONE EXTERNAL WOUND COVER
    K982067 MAGNETIC PORT SILICONE TISSUE EXPANDER
    K974653 SILICONE ELASTOMER SHEETING
    K974654 SILICONE BLOCKS
    K974209 SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
    K973656 DISPOSABLE SILICONE EPISTAXIS CATHETER
    K973082 VENTRAL WALL DEFECT REDUCTION SILO
    Search all 12 clearances from Specialty Surgical Products, Inc. →