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

    PROD. NO. 02-031 - LACERATION TRAY

    K Number: K963443 · Decision Oct 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    8
    Review Days
    48

    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
    PROD. NO. 02-031 - LACERATION TRAY
    K Number
    K963443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Continental Medical Laboratories, Inc.
    Date Received
    August 30, 1996
    Decision Date
    October 17, 1996
    Product Code
    LRO
    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
    LRO General Surgery Tray

    Similar 510(k) Clearances

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

    Medline General Surgery Tray

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medline Cardiovascular Procedure Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGICAL DRAPE KIT - D.I.R.R.A. SRL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMSINO TRACHEOSTOMY CARE TRAY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Continental Medical Laboratories, Inc.

    K Number Device Name
    K964827 PROD. NO. 01-132 - SUTURE REMOVAL KIT
    K963234 STAPLE REMOVAL KIT
    K962078 TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
    K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING
    K962073 URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    K952335 WOUND CARE MANAGEMENT KITS
    K905123 G-TUBE DRESSING CHANGE TRAY