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

    APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE

    K Number: K891212 · Decision Apr 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    38

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    Basic Information

    Device Name
    APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE
    K Number
    K891212
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pro-Safe Professional Linens, Inc.
    Date Received
    March 7, 1989
    Decision Date
    April 14, 1989
    Product Code
    FXO
    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
    FXO Suit, Surgical

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    Other Clearances by Pro-Safe Professional Linens, Inc.

    K Number Device Name
    K891210 POCKETED WRAPS #3009 A,B,C
    K891216 DENTAL EQUIPMENT PROTECTION DEVICES
    K891211 SURGICAL GOWN #2001
    K891213 SURGICAL INSTRUMENT POUCH #M102
    K891214 DENTAL SURGICAL WRAP #3007 A,B,C
    K891215 FAST WRAP #M 101