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

    TOWEL PACK

    K Number: K952759 · Decision Sep 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    11
    Review Days
    105

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    Basic Information

    Device Name
    TOWEL PACK
    K Number
    K952759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcare Custom Packaging, Inc.
    Date Received
    June 16, 1995
    Decision Date
    September 29, 1995
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Medcare Custom Packaging, Inc.

    K Number Device Name
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    K951149 SINGLE USE INSTRUMENT TRAY
    K934732 PELVIC EXAM TRAY
    K942000 BURN DRESSING TRAY
    K936261 CATHETER INSERTION TRAY
    K922179 CATHETER INSERTION TRAY
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