BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IV START KITS

    K Number: K943047 · Decision Sep 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    79

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    Basic Information

    Device Name
    IV START KITS
    K Number
    K943047
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterile Concepts, Inc.
    Date Received
    June 27, 1994
    Decision Date
    September 14, 1994
    Product Code
    KMK
    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
    KMK Device, Intravascular Catheter Securement

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    Other Clearances by Sterile Concepts, Inc.

    K Number Device Name
    K951231 ORTHOPEDIC PACKS
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    K951478 GENERAL AND PLASTIC SURGERY PACKS
    K944139 DENTAL HYGIENE TRAY
    K943090 SUTURE REMOVAL TRAYS
    K940864 DENTIST WITH ASSISTANT PACK
    K943046 SKIN STAPLE REMOVAL TRAYS
    K920763 LACERATTION TRAY