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

    DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)

    K Number: K021533 · Decision Mar 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    3
    Review Days
    299

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    Basic Information

    Device Name
    DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
    K Number
    K021533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Creative Contract (M) Sdn Bhd
    Date Received
    May 10, 2002
    Decision Date
    March 5, 2003
    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 Creative Contract (M) Sdn Bhd

    K Number Device Name
    K021546 DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
    K021539 DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS