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

    PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351

    K Number: K942475 · Decision Oct 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    11
    Review Days
    146

    Basic Information

    Device Name
    PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351
    K Number
    K942475
    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
    PROTECTAIDE, INC.
    Date Received
    May 25, 1994
    Decision Date
    October 18, 1994
    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 PROTECTAIDE, INC.

    K Number Device Name
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    K942476 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069
    K942470 PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315
    K942473 PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592
    K942472 PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123
    K942474 PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000
    K942471 PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777
    K942466 PROTECTAIDE CPR PROTECTION PACK NO. 17701
    K942467 PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000
    Search all 11 clearances from PROTECTAIDE, INC. →