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

    PROCEDURE MASKS: PM4-301 AND PM4-304

    K Number: K011789 · Decision Jun 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    9
    Review Days
    14

    Basic Information

    Device Name
    PROCEDURE MASKS: PM4-301 AND PM4-304
    K Number
    K011789
    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
    June 8, 2001
    Decision Date
    June 22, 2001
    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
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    K021864 PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
    K021076 PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    K001951 PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
    K971076 PRIMED SHOE COVERS, PRIMED HEAD COVERS
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