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

    CRYOSIL SILICONE GEL SHEETING

    K Number: K964047 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    5
    Review Days
    161

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    Basic Information

    Device Name
    CRYOSIL SILICONE GEL SHEETING
    K Number
    K964047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodermis Corp.
    Date Received
    October 9, 1996
    Decision Date
    March 19, 1997
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    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
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Biodermis Corp.

    K Number Device Name
    K003948 EPI-DERM SILICONE GEL SHEETING
    K992146 SCARAID SILICONE GEL SHEETING
    K991604 EPI-FOAM SILICONE SHEETING
    K942156 EPI-DERM SILICONE GEL SHEETING