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

    MOLNLYCKE ETE STERILE NON-ADHERENT DRESS

    K Number: K830166 · Decision Feb 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    22

    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
    MOLNLYCKE ETE STERILE NON-ADHERENT DRESS
    K Number
    K830166
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lada Intl., Inc.
    Date Received
    January 18, 1983
    Decision Date
    February 9, 1983
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

    Similar 510(k) Clearances

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

    IVALON EXTERNAL SPONGE

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

    ISOLYER (4X4, 8PLY)

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

    OMNISORB II, NONWOVEN SPONGE, STERILE AND NON

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

    MULTI-TRAUMA DRESSING

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

    K-BAND AND K-CREPE

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

    STERILE GAUZE PADS

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

    Other Clearances by Lada Intl., Inc.

    K Number Device Name
    K872833 BREATHGUARD APNEA MONITOR
    K861410 LIC MOBILE TRANSPORT STRETCHERS
    K830050 MOLNLYCKE MEPORE STERILE SELF-ADHESIVE
    K830051 MOLNLYCKE MESALT STERILE DRESSING
    K812141 LIC OBSTETRICAL TABLE
    K812142 LIC 180 MEDICAL LAMPS