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

    PRIMADERM

    K Number: K854740 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    10
    Review Days
    109

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    Basic Information

    Device Name
    PRIMADERM
    K Number
    K854740
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Absorbent Cotton Co., Inc.
    Date Received
    November 25, 1985
    Decision Date
    March 14, 1986
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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    Other Clearances by Absorbent Cotton Co., Inc.

    K Number Device Name
    K883250 STERI-CLENS WOUND CARE KIT
    K880613 ACCO(R) FACE MASK
    K875129 STERI-CLENS
    K874741 STERI-CLENS(TM) SURGICAL SCRUB SPONGE
    K873523 PLAIN DRY GAUZE
    K850126 OIL EMULSION NON-ADHERING DRESSING
    K844095 WET DRESSING WATER-STERILE
    K844096 WET DRESSING SALINE-STERILE
    K781727 CHANGE IN STERILIZATION PROCEDURE