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

    OMNISORB II, NONWOVEN SPONGE, STERILE AND NON

    K Number: K931610 · Decision Jun 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
    K Number
    K931610
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omni Mfg., Inc.
    Date Received
    April 1, 1993
    Decision Date
    June 24, 1993
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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