BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLIGHT SOCK

    K Number: K040353 · Decision Mar 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    28

    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
    FLIGHT SOCK
    K Number
    K040353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ssl Americas, Inc.
    Date Received
    February 12, 2004
    Decision Date
    March 11, 2004
    Product Code
    DWL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

    Similar 510(k) Clearances

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

    MEDLINE ANTI-EMBOLISM STOCKING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENCIRCLE COMPRESSION THERAPY STOCKING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Ssl Americas, Inc.

    K Number Device Name
    K072169 DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
    K063385 DUREX PLAY MASSAGE GEL LUBRICANT
    K060098 DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
    K042958 DUREX PLAY TINGLING LUBRICANT
    K042470 DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
    K042563 DUREX PLAY WARMER LUBRICANT
    K032227 DUREX FLAVORED LATEX CONDOM
    K032124 DUREX PLAY LUBRICANT
    K020659 DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT