BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Safe Secure Sterilization Pouches and Rolls

    K Number: K180139 · Decision Jan 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    316
    Applicant Total
    1
    Review Days
    350

    Basic Information

    Device Name
    Safe Secure Sterilization Pouches and Rolls
    K Number
    K180139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safe Secure Packing Co., Ltd.
    Date Received
    January 18, 2018
    Decision Date
    January 3, 2019
    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.

    Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GCI Sterilization Wrappers

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Self Sealing Sterilization Pouches

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Package/Reel

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medicom Sterilization Pouch and Reel

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