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

    KAPTON PEEL POUCH

    K Number: K933228 · Decision Mar 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    271

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    Basic Information

    Device Name
    KAPTON PEEL POUCH
    K Number
    K933228
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Fluoroseal Corp.
    Date Received
    July 2, 1993
    Decision Date
    March 30, 1994
    Product Code
    KJA
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KJA Flask, Tissue Culture

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