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

    VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES

    K Number: K031748 · Decision Aug 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
    K Number
    K031748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalcare Group, Inc.
    Date Received
    June 5, 2003
    Decision Date
    August 27, 2003
    Product Code
    EZL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Vitalcare Group, Inc.

    K Number Device Name
    K060109 OMI RETRACTABLE SAFETY SYRINGE
    K050906 VITALCARE I.V. ADMINISTRATION SET
    K040916 VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
    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