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

    STERILIZATION PROCESS CHANGE BOUNDARY

    K Number: K792621 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    72
    Review Days
    23

    Basic Information

    Device Name
    STERILIZATION PROCESS CHANGE BOUNDARY
    K Number
    K792621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    PROCTER & GAMBLE MFG. CO.
    Date Received
    December 19, 1979
    Decision Date
    January 11, 1980
    Product Code
    KKX
    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
    KKX Drape, Surgical

    Similar 510(k) Clearances

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

    BeneHold™ Surgical Incise Drape with CHG antimicrobial II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BeneHold Surgical Incise Drape with CHG antimicrobial

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ControlRad Sterile Cover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MediClear PreOp

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Plus Surgical Drapes (EO Sterilized), PMDB-XXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by PROCTER & GAMBLE MFG. CO.

    K Number Device Name
    K873036 ATTENDS INCONTINENT BRIEF
    K873457 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
    K864673 UNSCENTED MENSTRUAL PAD
    K861863 MODIFIED PROTECTIVE GARMENT
    K862348 SINGLE-USE PATIENT UNDERPAD
    K860598 MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
    K853880 ATTENDS DISPOS. UNDERPAD
    K853000 SCENTED ALWAYS PANTILINERS
    K852985 UNSCENTED ALWAYS PANTILINERS
    K850955 ALWAYS MAXIPADS - UNSCENTED
    Search all 72 clearances from PROCTER & GAMBLE MFG. CO. →