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

    AMSINO TRACHEOSTOMY CARE TRAY

    K Number: K023276 · Decision Dec 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    28
    Review Days
    69

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    Basic Information

    Device Name
    AMSINO TRACHEOSTOMY CARE TRAY
    K Number
    K023276
    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
    Amsino International, Inc.
    Date Received
    October 1, 2002
    Decision Date
    December 9, 2002
    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

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    Other Clearances by Amsino International, Inc.

    K Number Device Name
    K252543 AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
    K220230 AMSure Enteral Feeding Pump
    K220267 AMSafe NeuFlo Needleless Connector
    K213522 AMSafe Pre-Filled Normal Saline Flush Syringe
    K200051 PUGGLE Enteral Feeding Pump and Feeding Set
    K183473 AMSafe(R) Pre-Filled Normal Saline Flush Syringe
    K181445 AMSure Hydrophilic Intermittent Catheter
    K181423 AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
    K173665 AMSafe Sure-Lok Needle-Free Connector
    K181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
    Search all 28 clearances from Amsino International, Inc. →