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

    X-LARGE MULTI-FUNCTION TRAUMA DRESSING

    K Number: K940358 · Decision Mar 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    17
    Review Days
    57

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    Basic Information

    Device Name
    X-LARGE MULTI-FUNCTION TRAUMA DRESSING
    K Number
    K940358
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Certified Safety Mfg., Inc.
    Date Received
    January 25, 1994
    Decision Date
    March 23, 1994
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

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    Other Clearances by Certified Safety Mfg., Inc.

    K Number Device Name
    K960587 CPROTECTOR 2000
    K960615 GAUZE COMPRESS
    K960624 CERTI COOL INSTANT COLD COMPRESS
    K953102 BLOODBORNE PATHOGEN KIT
    K946338 CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
    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
    K940333 EYE PAD
    Search all 17 clearances from Certified Safety Mfg., Inc. →