BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NEZHAT-DORSEY THERMAL RETENTION SYSTEM

    K Number: K951300 · Decision Jun 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    18
    Review Days
    90

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    Basic Information

    Device Name
    NEZHAT-DORSEY THERMAL RETENTION SYSTEM
    K Number
    K951300
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Hydro-Surgical Instruments, Inc.
    Date Received
    March 22, 1995
    Decision Date
    June 20, 1995
    Product Code
    LHC
    Advisory Committee
    Physical Medicine
    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
    LHC Warmer, Irrigation Solution

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    Other Clearances by American Hydro-Surgical Instruments, Inc.

    K Number Device Name
    K953574 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
    K953481 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
    K952070 NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
    K946380 NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
    K950499 NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
    K951119 NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
    K952421 NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
    K951733 NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS
    K951732 NEZHAT-DORESEY PENCIL-GRIP HANDLES
    K951731 NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
    Search all 18 clearances from American Hydro-Surgical Instruments, Inc. →