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

    VITALCARE DISPOSABLE VAGINAL SPECULUM

    K Number: K983716 · Decision Dec 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    VITALCARE DISPOSABLE VAGINAL SPECULUM
    K Number
    K983716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vitalcare Group, Inc.
    Date Received
    October 21, 1998
    Decision Date
    December 23, 1998
    Product Code
    HIB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIB Speculum, Vaginal, Nonmetal

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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
    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
    K982901 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED