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

    MICRO-COLL COLLAGEN WOUND SPRAY

    K Number: K912565 · Decision Jun 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    366

    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
    MICRO-COLL COLLAGEN WOUND SPRAY
    K Number
    K912565
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Coll
    Date Received
    June 11, 1991
    Decision Date
    June 11, 1992
    Product Code
    SEJ
    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
    SEJ Wound Dressings Containing Topical Analgesics

    Similar 510(k) Clearances

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

    AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALLWOUND

    FDA 510(k)
    FDA Unclassified ·Unknown

    REGENECARE WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    FREEDOM, MODEL 4660

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEMO-STAT

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all