BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    PRIMED PRIME-PLUS COTTON GAUZE SPONGES

    K Number: K971075 · Decision Jun 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    PRIMED PRIME-PLUS COTTON GAUZE SPONGES
    K Number
    K971075
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Primeline Medical Products, Inc.
    Date Received
    March 24, 1997
    Decision Date
    June 22, 1997
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.

    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE

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    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

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    FDA Unclassified ·Unknown

    VITOP DRESSING

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    FDA Unclassified ·Unknown

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    FDA Unclassified ·Unknown

    CROSSTEX NON-WOVEN SPONGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    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
    K971076 PRIMED SHOE COVERS, PRIMED HEAD COVERS