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

    HOLLISTER ODOR ABSORBING WOUND PAD

    K Number: K820464 · Decision Mar 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    85
    Review Days
    29

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    Basic Information

    Device Name
    HOLLISTER ODOR ABSORBING WOUND PAD
    K Number
    K820464
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hollister, Inc.
    Date Received
    February 22, 1982
    Decision Date
    March 23, 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 Hollister, Inc.

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    K083153 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
    K050483 EVADRI BLADDER CONTROL SYSTEMS
    K040779 RESTORE WOUND CLEANSER
    K013612 INCARE PELVIC FLOOR THERAPY SYSTEM
    K013653 INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
    K013483 INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
    K013345 INCARE INTERMITTENT CATHETER
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