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

    DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER

    K Number: K082208 · Decision Dec 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    500
    Registration Numbers
    500
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    118

    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
    DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
    K Number
    K082208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scivolutions, Inc.
    Date Received
    August 5, 2008
    Decision Date
    December 1, 2008
    Product Code
    NAC
    Advisory Committee
    General, Plastic Surgery
    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
    NAC Dressing, Wound, Hydrophilic

    Similar 510(k) Clearances

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

    HYDRASORB JOYCE SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SORBSAN TOPICAL WOUND DRESSING (MODIFIED)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ALGINATE FIBER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Scivolutions, Inc.

    K Number Device Name
    K020318 SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES