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

    UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE

    K Number: K993996 · Decision Jul 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    236

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    Basic Information

    Device Name
    UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
    K Number
    K993996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Univec, Inc.
    Date Received
    November 24, 1999
    Decision Date
    July 17, 2000
    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 Univec, Inc.

    K Number Device Name
    K020500 UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
    K000747 UNIVEC TWO PIECE SYRINGE
    K961877 PISTON SYRINGE
    K933469 UNIVEC NON-REUSABLE SYRINGE
    K951619 UNIVEC NONREUSABLE LOCKING SYRINGE
    K943679 UNIVEC NONRESUSABLE LOCKING SYRINGE