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

    OMI RETRACTABLE SAFETY SYRINGE

    K Number: K060109 · Decision May 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    8
    Review Days
    112

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    Basic Information

    Device Name
    OMI RETRACTABLE SAFETY SYRINGE
    K Number
    K060109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalcare Group, Inc.
    Date Received
    January 13, 2006
    Decision Date
    May 5, 2006
    Product Code
    MEG
    Advisory Committee
    General Hospital
    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
    MEG Syringe, Antistick

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    Other Clearances by Vitalcare Group, Inc.

    K Number Device Name
    K050906 VITALCARE I.V. ADMINISTRATION SET
    K040916 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
    K031748 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    K992289 VINYL POWDERED EXAM GLOVE / CAT.# 15-020
    K983016 GAUZE, SPONGES, CAT # 11-003
    K983716 VITALCARE DISPOSABLE VAGINAL SPECULUM
    K982901 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED