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

    AEGIS NON-ADHERENT DRESSING

    K Number: K820413 · Decision Mar 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    AEGIS NON-ADHERENT DRESSING
    K Number
    K820413
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Professional Medical Products, Inc.
    Date Received
    February 12, 1982
    Decision Date
    March 12, 1982
    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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    Other Clearances by Professional Medical Products, Inc.

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    K862010 CHICK SURGICAL LIGHT
    K860739 CHICK SURIGICAL LIGHT
    K834478 CHICK/REISON PATIENT EMERG. TROLLEY
    K830825 YIELD NON-ADHERENT DRESSING
    K822713 DERM-A-TEC SKIN BARRIER FILM