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

    ISO-CARE KIT

    K Number: K781539 · Decision Nov 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    56

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    Basic Information

    Device Name
    ISO-CARE KIT
    K Number
    K781539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4440
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Nice-Pak Products, Inc.
    Date Received
    September 8, 1978
    Decision Date
    November 3, 1978
    Product Code
    HMP
    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
    HMP Pad, Eye

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    Other Clearances by Nice-Pak Products, Inc.

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    K974768 PDI STERILE LUBRICATING JELLY
    K840342 PDI PREPMASTER WET PACK PATIENT PREP KIT
    K840343 PDI PREPMASTER WET PACK VAGINAL-X21477
    K840344 PDI PREPMASTER WET PACK MINOR PROCEDURE
    K833549 PDI SURGICAL SCRUB/BRUSH T150-70
    K810337 PDI SURGICAL SCRUB SPONGE-BRUSH-T15070
    K780279 ICE-PAK, PDI
    K780400 DEN-Z-ORB