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

    CLEAN-SORB

    K Number: K941099 · Decision Sep 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    7
    Review Days
    207

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    Basic Information

    Device Name
    CLEAN-SORB
    K Number
    K941099
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospital Specialty Co.
    Date Received
    March 7, 1994
    Decision Date
    September 30, 1994
    Product Code
    EFQ
    Advisory Committee
    Unknown
    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
    EFQ Gauze/Sponge, Internal

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    GAUZE, SPONGES, CAT # 11-003

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    Other Clearances by Hospital Specialty Co.

    K Number Device Name
    K990861 WOUND DRESSING/ABD PAD, MODEL #10810
    K882094 GARDS DEODORANT SANITARY NAPKIN
    K880454 AT EASE STRESS PAD
    K880455 AT EASE ADULT DIAPER
    K822242 SANITARY/OB NAPKINS
    K822433 GARDS (UNSCENTED, MENSTRUAL PAD)