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

    OVERDOSE KIT

    K Number: K770238 · Decision Apr 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    56
    Review Days
    57

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    Basic Information

    Device Name
    OVERDOSE KIT
    K Number
    K770238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Hospital Supply Corp.
    Date Received
    February 7, 1977
    Decision Date
    April 5, 1977
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    TX
    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

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    Other Clearances by American Hospital Supply Corp.

    K Number Device Name
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    K830546 DOSIMETRIC RELEASE
    K822990 CONVERTORS PRIMARY WOUND DRESSING II
    K830343 CONTAINER W/PRIMING SOLUTION
    K830301 STRATUS FLUOROMETRIC ENZYME IMMUN0-
    K822755 LATEX PENROSE TUBING
    K823418 HEYER-SCHUTE UNIVERSAL URETERAL STENT
    K822966 CONVERTORS DISPOSABLE DRESSING SPONGE
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