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

    4 SURE TM ENTERAL FEEDING BAG

    K Number: K922402 · Decision Mar 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    11
    Review Days
    673

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    Basic Information

    Device Name
    4 SURE TM ENTERAL FEEDING BAG
    K Number
    K922402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Pacific Medical, Inc.
    Date Received
    May 21, 1992
    Decision Date
    March 25, 1994
    Product Code
    FPD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPD Tube, Feeding

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    Other Clearances by Boston Pacific Medical, Inc.

    K Number Device Name
    K933109 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
    K931048 4-SURE NELATON CATHETER
    K931047 4-SURE FEMALE CATHETER
    K921852 4 SURE TM RECTAL TUBE
    K921853 4 SURE TM FEEDING TUBES
    K921851 4 SURE TM SUCTION CATHETERS & KITS
    K922398 4 SURE TM ENEMA BAG SET
    K922397 4 SURE TM NASAL OXYGEN CANNULA
    K924995 4 SURE TM ANESTHESIA EXTENSION SET
    K922401 4 SURE TM COLOSTOMY POUCH
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