BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM

    K Number: K021076 · Decision Apr 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    K Number
    K021076
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Primeline Medical Products, Inc.
    Date Received
    April 3, 2002
    Decision Date
    April 16, 2002
    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 Primeline Medical Products, Inc.

    K Number Device Name
    K023266 PRIMAGARD SURGICAL GOWNS
    K023117 PRIMAGARD SURGICAL GOWNS
    K022868 PRIMAGARD SURGICAL EQUIPMENT DRAPES
    K021864 PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
    K011789 PROCEDURE MASKS: PM4-301 AND PM4-304
    K001951 PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
    K971076 PRIMED SHOE COVERS, PRIMED HEAD COVERS
    K971075 PRIMED PRIME-PLUS COTTON GAUZE SPONGES