BEUDAMED
    FDA Registration Active 🇺🇸 United States

    P300-1AHA

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NSK AMERICA CORP.
    Registration Number
    1422375
    FEI Number
    1000139790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 Global Parkway
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202120

    Owner / Operator

    Firm Name
    NAKANISHI INC.
    Operator Number
    8030216
    Address
    1800 Global Pkwy
    City
    Hoffman Est
    State
    IL
    Postal Code
    60192
    Country
    US
    Correspondent
    Satoru Ikeda

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    P300-1AHA P300-2A80 P300-1AHS P300-2S60 P300-2S80 P300-2A60 P300-1T130-C P300-2S40 P300-1T110-PB P300-1T130-PB P300-2A20 P300-1T110-C P300-1T170 P300-2S20 P300-1T110 P300-1T240 NSK Sterile Burs/Drills P300-2A40 P300-1T130 P300-2A10 P300-2S10

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198