BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    PRIMED SHOE COVERS, PRIMED HEAD COVERS

    K Number: K971076 · Decision Jan 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    282
    Registration Numbers
    282
    Same Product Code
    35
    Applicant Total
    9
    Review Days
    295

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    Basic Information

    Device Name
    PRIMED SHOE COVERS, PRIMED HEAD COVERS
    K Number
    K971076
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Primeline Medical Products, Inc.
    Date Received
    March 24, 1997
    Decision Date
    January 13, 1998
    Product Code
    FXP
    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
    FXP Cover, Shoe, Operating-Room

    Similar 510(k) Clearances

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    NIOMED NON-SKID SHOE COVERS

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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)
    K021076 PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
    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
    K971075 PRIMED PRIME-PLUS COTTON GAUZE SPONGES