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

    SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT

    K Number: K923283 · Decision Jan 4, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    182

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    Basic Information

    Device Name
    SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT
    K Number
    K923283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Savoy Medical Supply Co., Inc.
    Date Received
    July 6, 1992
    Decision Date
    January 4, 1993
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Savoy Medical Supply Co., Inc.

    K Number Device Name
    K922133 HOSPITAL KIT SV 105
    K922130 HOSPITAL KIT DK 117
    K922127 HOSPITAL KIT GP 103
    K923281 SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
    K922128 HOSPITAL KIT EP 104
    K922126 HOSPITAL KIT ENT 1125