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

    NON STERILE PARENTERAL SUPPLY KIT

    K Number: K900857 · Decision May 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    16
    Review Days
    88

    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
    NON STERILE PARENTERAL SUPPLY KIT
    K Number
    K900857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Intermed, Inc.
    Date Received
    February 23, 1990
    Decision Date
    May 22, 1990
    Product Code
    FMF
    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
    FMF Syringe, Piston

    Similar 510(k) Clearances

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

    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Instylla Delivery Kit

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

    Other Clearances by Intermed, Inc.

    K Number Device Name
    K842166 INTERMED, INS STERILE WATER/SALINE
    K833126 DRESSING CHANGE TRAYS
    K833574 PERCUTANEOUS SHEATH INTRODUCER TRAYS
    K833573 CENTRAL VEIN CATH. TRAY CC-20-1420
    K833139 ACUTE HEMODIALYSIS TRAYS
    K833059 SUCTION CATHETER TRAYS
    K821269 TRACHEOSTOMY CARE TRAYS
    K791427 CATHETERIZATION TRAYS FOLEY AND URETHRAL
    K791426 PERITONEAL PAC
    K781748 IRRIGATION TRAY
    Search all 16 clearances from Intermed, Inc. →