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

    AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

    K Number: K963293 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    25
    Review Days
    219

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    Basic Information

    Device Name
    AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
    K Number
    K963293
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Augustine Medical, Inc.
    Date Received
    August 21, 1996
    Decision Date
    March 28, 1997
    Product Code
    MSA
    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
    MSA Dressing, Wound And Burn, Occlusive, Heated

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    MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX

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