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

    COMPLEAT SURGICAL MASK

    K Number: K962654 · Decision Jan 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    7
    Review Days
    203

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    Basic Information

    Device Name
    COMPLEAT SURGICAL MASK
    K Number
    K962654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carl Parker Associates, Inc.
    Date Received
    July 8, 1996
    Decision Date
    January 27, 1997
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    Other Clearances by Carl Parker Associates, Inc.

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    K932056 DEFEND SELF-SEALING STERILIZATION POUCH
    K891308 STERILE SURGICAL GLOVES
    K891257 DEFEND LATEX EXAMINATION GLOVES
    K891157 DEFEND LATEX EXAMINATION GLOVES
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