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

    DRESSING CHANGE TRAY

    K Number: K920339 · Decision Apr 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    8
    Review Days
    90

    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
    DRESSING CHANGE TRAY
    K Number
    K920339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medikmark, Inc.
    Date Received
    January 24, 1992
    Decision Date
    April 23, 1992
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

    Similar 510(k) Clearances

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

    Dukal Crepe Paper Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch/Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Self-Seal Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chex-All Sterilization Pouches and Tubes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch and Roll

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

    Other Clearances by Medikmark, Inc.

    K Number Device Name
    K953474 IV START KIT
    K923960 UPPER EXTERMITY DRAPE KIT
    K921730 C-SECTION PACK
    K921733 TRACHEOSTOMY CARE TRAY
    K921732 MINOR LAP SET
    K920341 LACERATION TRAYS
    K920340 SUTURE REMOVAL KIT