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

    HYDROGEL SKIN DRESSING

    K Number: K962352 · Decision Aug 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    16
    Review Days
    45

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    Basic Information

    Device Name
    HYDROGEL SKIN DRESSING
    K Number
    K962352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    June 18, 1996
    Decision Date
    August 2, 1996
    Product Code
    NAE
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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    Other Clearances by North American Sterilization & Packaging Co.

    K Number Device Name
    K964231 NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
    K963753 NASP TRANSPARENT DRESSING
    K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
    K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    K911865 NORTEC CONNECTING TUBE SET
    K911784 NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K910691 NORTEC URETERAL STENT
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES
    Search all 16 clearances from North American Sterilization & Packaging Co. →