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

    FASTSEAL CHEST WOUND DRESSING

    K Number: K990079 · Decision Dec 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    346

    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
    FASTSEAL CHEST WOUND DRESSING
    K Number
    K990079
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Greenfield Medical Technologies, Inc.
    Date Received
    January 11, 1999
    Decision Date
    December 23, 1999
    Product Code
    MGP
    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
    MGP Dressing, Wound And Burn, Occlusive

    Similar 510(k) Clearances

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

    COLLATEK FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    COLLATEK SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    LASERSKIN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SIMPLICARE TRANSPARENT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS

    FDA 510(k)
    FDA Unclassified ·Unknown

    GILTECH PLUS TRANSPARENT DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all