BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CP & S STERILE BURN SHEET

    K Number: K930759 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    16
    Applicant Total
    7
    Review Days
    343

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CP & S STERILE BURN SHEET
    K Number
    K930759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5180
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Products & Services, Inc.
    Date Received
    February 12, 1993
    Decision Date
    January 21, 1994
    Product Code
    FPY
    Advisory Committee
    General Hospital
    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
    FPY Sheet, Burn

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPY), ordered by most recent decision date.

    BURNSHIELD TRAUMA DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BURNSHIELD FIRE BLANKET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BURN SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BURNS CASUALTY SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BURNS CASUALTY SHEET LIMB WRAP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BURNS CASUALTY SHEET BURN ROLL

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Consolidated Products & Services, Inc.

    K Number Device Name
    K974190 CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
    K890551 URINARY DRAINAGE UNIT
    K890550 CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
    K890552 CP&S GAVAGE CONSTAINER, DISPOSABLE
    K890553 CP&S DISPOSABLE INSTANT COLD COMPRESS
    K890554 CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS