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

    ALLERGIST PACK SYRINGES

    K Number: K771359 · Decision Aug 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    24
    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
    ALLERGIST PACK SYRINGES
    K Number
    K771359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    July 25, 1977
    Decision Date
    August 22, 1977
    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 Pharmaseal Div., Baxter Healthcare Corp.

    K Number Device Name
    K792369 HYPERALIMENTATION DRESSING TRAY
    K792141 CONTINUOUS FLUSH DEVICE
    K792019 PHADECODE XA INHIBITOR ASSAY
    K791773 VENTILATOR TUBE WITH FILTER
    K791156 AMIPAQUE MYELOGRAM TRAY
    K790896 TWO-WAY ANESTHESIA FILTER
    K790409 LOW DEAD SPACE INSULIN SYRINGE
    K782069 TRAY, AUXILLARY BLOCK
    K781797 PREP TRAY, PREOPERATIVE SKIN
    K781680 MONITORING, PRESSURE KIT
    Search all 24 clearances from Pharmaseal Div., Baxter Healthcare Corp. →