BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SEPP ADHESIVE REMOVER

    K Number: K934790 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    11
    Applicant Total
    13
    Review Days
    157

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    Basic Information

    Device Name
    SEPP ADHESIVE REMOVER
    K Number
    K934790
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4730
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    October 5, 1993
    Decision Date
    March 11, 1994
    Product Code
    KOX
    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
    KOX Solvent, Adhesive Tape

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    Other Clearances by Medi-Flex Hospital Products, Inc.

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    K952007 ADHEROL SEPP APPLICATOR
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
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    K930196 CEPTI-SEAL I.V. PREP KIT
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