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

    VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION

    K Number: K971802 · Decision Jul 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    12
    Review Days
    76

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    Basic Information

    Device Name
    VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
    K Number
    K971802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Louisville Laboratories, Inc.
    Date Received
    May 15, 1997
    Decision Date
    July 30, 1997
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Louisville Laboratories, Inc.

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    K971791 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
    K971797 LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
    K971801 LAPAROTOMY BLADDER NECK SUSPENSION KIT
    K963076 LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
    K960882 CONTROL SYRINGE
    K955535 LOUISVILLE LABS OXYGEN HEAD TENT
    K946282 UNIVERSAL URETHRAL CATHETER
    K932979 EXTERNAL STABILITY PAD
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