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510(k) Data Aggregation

    K Number
    K960048
    Device Name
    EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
    Manufacturer
    SAFETEC OF AMERICA, INC.
    Date Cleared
    1996-07-12

    (190 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFETEC OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K960073
    Device Name
    EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
    Manufacturer
    SAFETEC OF AMERICA, INC.
    Date Cleared
    1996-07-12

    (189 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFETEC OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

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    K Number
    K953461
    Device Name
    CPR MASK & RELATED FAMILY KITS
    Manufacturer
    SAFETEC OF AMERICA, INC.
    Date Cleared
    1996-01-04

    (164 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFETEC OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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