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

    POS-T-VAC ID-300

    K Number: K961309 · Decision Jun 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    12
    Review Days
    67

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    Basic Information

    Device Name
    POS-T-VAC ID-300
    K Number
    K961309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pos-T-Vac, Inc.
    Date Received
    April 4, 1996
    Decision Date
    June 10, 1996
    Product Code
    KZH
    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
    KZH Introducer, Syringe Needle

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    Other Clearances by Pos-T-Vac, Inc.

    K Number Device Name
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    K983246 POS-T-VAC (IVP-600)
    K983245 POS-T-VAC (AVP-1000)
    K981180 REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
    K981011 POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
    K960828 POS-T-VAC B-10 BAND KIT
    K960342 POS-T-VAC AVP-1000 & MVP-700
    Search all 12 clearances from Pos-T-Vac, Inc. →