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

    PROCEDURE SPECIFIC KITS

    K Number: K964168 · Decision Mar 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    31
    Review Days
    137

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    Basic Information

    Device Name
    PROCEDURE SPECIFIC KITS
    K Number
    K964168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sage Products, Inc.
    Date Received
    October 17, 1996
    Decision Date
    March 3, 1997
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    Other Clearances by Sage Products, Inc.

    K Number Device Name
    K972705 RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
    K980490 SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
    K973911 2 GALLON ALTERNATE CARE SHARPS CONTAINER
    K972279 SHARPS SHUTTLE
    K970135 NITRILE GLOVES
    K972302 POCKET COUNT OR SAFETCOUNT
    K963986 STP SYSTEM PVA WITH ZINC
    K964026 STP SYSTEM - SAF
    K964027 STP SYSTEM-PVA WITH MERCURY
    K962168 MUCUS SPECIMEN TRAP
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