LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082782
    Device Name
    REPLICATION MEDICAL VESSEL GUARD
    Manufacturer
    REPLICATION MEDICAL INC
    Date Cleared
    2009-04-02

    (192 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPLICATION MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
    Device Description
    The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.
    Ask a Question

    Page 1 of 1