BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HYDRASORB(TM)

    K Number: K897102 · Decision Apr 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    4
    Review Days
    123

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    Basic Information

    Device Name
    HYDRASORB(TM)
    K Number
    K897102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Avitar, Inc.
    Date Received
    December 21, 1989
    Decision Date
    April 23, 1990
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Avitar, Inc.

    K Number Device Name
    K973260 HYDRASORB STERILE DRESSING
    K925841 HYDRASORB JOYCE SPONGE
    K897156 HYDRASORB(TM)