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

    PHOENIX DRAPES WITH MICROBAN

    K Number: K890917 · Decision Aug 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    11
    Review Days
    175

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PHOENIX DRAPES WITH MICROBAN
    K Number
    K890917
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Phoenix Medical Technology, Inc.
    Date Received
    February 23, 1989
    Decision Date
    August 17, 1989
    Product Code
    KGX
    Advisory Committee
    General Hospital
    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
    KGX Tape And Bandage, Adhesive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.

    SERAGARD INJECTION PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARE BAND ANTIBACTERIAL BANDAGES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYVEK PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADHESIVE BANDAGES WITH OTC DRUG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TARGETT PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARALLEL

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Phoenix Medical Technology, Inc.

    K Number Device Name
    K000223 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
    K945045 PATIENT EXAINATION GLOVES
    K905031 PATIENT EXAMINATION GLOVES
    K900453 MODIFIED SINGLE USE LATEX EXAMINATION GLOVES
    K900454 MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES
    K892976 SINGLE USE VINYL EXAM GLOVES - COLOR CODED
    K892975 LOW POWDER SINGLE USE LATEX EXAM GLOVES
    K891949 PATIENT EXAMINATION GLOVES (LATEX)
    K891132 PATIENT EXAMINATION GLOVE
    K853993 DOBE (MODIFIED)
    Search all 11 clearances from Phoenix Medical Technology, Inc. →