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

    SILICONE BLOCKS

    K Number: K974654 · Decision Feb 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    12
    Review Days
    71

    Basic Information

    Device Name
    SILICONE BLOCKS
    K Number
    K974654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Received
    December 15, 1997
    Decision Date
    February 24, 1998
    Product Code
    MIB
    Advisory Committee
    Ear, Nose, Throat
    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
    MIB Elastomer, Silicone Block

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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
    K982258 MAMMARY SIZER
    K982065 STERILE SILICONE EXTERNAL WOUND COVER
    K982067 MAGNETIC PORT SILICONE TISSUE EXPANDER
    K974653 SILICONE ELASTOMER SHEETING
    K974209 SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
    K973656 DISPOSABLE SILICONE EPISTAXIS CATHETER
    K973082 VENTRAL WALL DEFECT REDUCTION SILO
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