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

    S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

    K Number: K872714 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    24
    Review Days
    11

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
    K Number
    K872714
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Roseburg SA
    Date Received
    July 10, 1987
    Decision Date
    July 21, 1987
    Product Code
    GBI
    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
    GBI Material, External Aesthetic Restoration, Used With Adhesive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GBI), ordered by most recent decision date.

    FACTOR II PROSTHETIC SILICONE ELASTOMER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AHH NATURAL BREAST FORM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AMOENA BREAST FORMS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AMOENA BREAST FORMS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PROSTHESIS OR SURGICAL PADS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Roseburg SA

    K Number Device Name
    K931155 STAPLE, FIXATION BONE; SCREW FIXATION BONE
    K890081 CALIUS-ISABEL CANOVAS SUNGLASSES
    K885275 ASSENAT-BLESCHET SUNGLASSES
    K882392 BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES
    K872715 UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
    K874317 POIRIER KID-ROLLER MANUAL WHEELCHAIR
    K871688 SPECTACLE FRAME - DANIELLE
    K871689 SPECTACLE FRAME - LORRAINE
    K870654 EFER ARTHROSCOPE
    K864436 STAVIP 3000
    Search all 24 clearances from Roseburg SA →