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

    EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP

    K Number: K960073 · Decision Jul 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    4
    Review Days
    189

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    Basic Information

    Device Name
    EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
    K Number
    K960073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Safetec of America, Inc.
    Date Received
    January 5, 1996
    Decision Date
    July 12, 1996
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Safetec of America, Inc.

    K Number Device Name
    K960048 EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
    K953461 CPR MASK & RELATED FAMILY KITS
    K952962 EZ-PERSONAL PROTECTION KIT