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

    SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT

    K Number: K923281 · Decision Mar 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    840
    Registration Numbers
    840
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    263

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    Basic Information

    Device Name
    SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
    K Number
    K923281
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Savoy Medical Supply Co., Inc.
    Date Received
    July 6, 1992
    Decision Date
    March 26, 1993
    Product Code
    MDM
    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
    MDM Instrument, Manual, Surgical, General Use

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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
    K922128 HOSPITAL KIT EP 104
    K922126 HOSPITAL KIT ENT 1125
    K923283 SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT