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

    MEDCHEM SURGICAL DELIVERY SYSTEM

    K Number: K932466 · Decision Aug 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    80

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    Basic Information

    Device Name
    MEDCHEM SURGICAL DELIVERY SYSTEM
    K Number
    K932466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medco Products, Co., Inc.
    Date Received
    May 21, 1993
    Decision Date
    August 9, 1993
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Medco Products, Co., Inc.

    K Number Device Name
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    K860099 MEDCO-SONIC NQ-2000
    K852015 JYROCHAIR, MODEL SK-H
    K851659 SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
    K844580 MEDCOLATOR MODEL HVX
    K842712 MEDCOLATOR MODEL GX
    K822829 ROTARY VASCULAR KNIFE