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

    PDI PREPMASTER WET PACK MINOR PROCEDURE

    K Number: K840344 · Decision Mar 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    9
    Review Days
    80

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    Basic Information

    Device Name
    PDI PREPMASTER WET PACK MINOR PROCEDURE
    K Number
    K840344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Nice-Pak Products, Inc.
    Date Received
    January 6, 1984
    Decision Date
    March 26, 1984
    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

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    K833549 PDI SURGICAL SCRUB/BRUSH T150-70
    K810337 PDI SURGICAL SCRUB SPONGE-BRUSH-T15070
    K781539 ISO-CARE KIT
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