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

    INTERPRO INT'L, INC. ISOLATION GOWN

    K Number: K874766 · Decision Dec 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    11
    Review Days
    21

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    Basic Information

    Device Name
    INTERPRO INT'L, INC. ISOLATION GOWN
    K Number
    K874766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Interpro Intl., Inc.
    Date Received
    November 19, 1987
    Decision Date
    December 10, 1987
    Product Code
    FYC
    Advisory Committee
    General, Plastic Surgery
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Interpro Intl., Inc.

    K Number Device Name
    K890968 VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
    K890891 LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL)
    K891642 PATIENT EXAMINATION GLOVES (LATEX)
    K891438 PATIENT EXAMINATION GLOVES (LATEX)
    K891440 PATIENT EXAMINATION GLOVES (LATEX)
    K881374 SURGEONS GLOVES
    K874067 GUAZE SPONGES
    K874066 SURGICAL CAPS
    K874064 SHOE COVERS
    K874065 LAPAROTOMY SPONGES
    Search all 11 clearances from Interpro Intl., Inc. →