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

    BLOODBORNE PATHOGEN KIT

    K Number: K953102 · Decision Dec 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    17
    Review Days
    161

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    Basic Information

    Device Name
    BLOODBORNE PATHOGEN KIT
    K Number
    K953102
    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
    Certified Safety Mfg., Inc.
    Date Received
    July 3, 1995
    Decision Date
    December 11, 1995
    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 Certified Safety Mfg., Inc.

    K Number Device Name
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    K945004 2, 3 & 4 BANDADGE COMPRESS
    K945002 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
    K940249 CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
    K941311 FIRST AID/TRUMA KIT
    K940358 X-LARGE MULTI-FUNCTION TRAUMA DRESSING
    K940333 EYE PAD
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