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510(k) Data Aggregation

    K Number
    K053637
    Device Name
    MANI NEEDLE & SUTURE PACK (NYLON)
    Manufacturer
    MANI, INC.
    Date Cleared
    2006-05-19

    (141 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MANI Needle & Suture Pack (Nylon) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
    Device Description
    The MANI Needle & Suture Pack (Nylon) consists of a stainless steel needle and Nylon suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
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    K Number
    K053638
    Device Name
    MANI NEEDLE & SUTURE PACK (SILK)
    Manufacturer
    MANI, INC.
    Date Cleared
    2006-05-19

    (141 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
    Device Description
    The MANI Needle & Suture Pack (Silk) consists of a stainless steel needle and silk suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
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    K Number
    K053636
    Device Name
    MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
    Manufacturer
    MANI, INC.
    Date Cleared
    2006-03-14

    (75 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MANI Needle & Suture Pack (PGA Absorbable) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
    Device Description
    The MANI Needle & Suture Pack (PGA Absorbable) consists of a stainless steel needle and PGA Absorbable suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
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    K Number
    K050150
    Device Name
    MANI NEEDLE & SUTURE PACK
    Manufacturer
    MANI, INC.
    Date Cleared
    2005-12-05

    (315 days)

    Product Code
    GATGDL
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MANI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.
    Device Description
    The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) consists of a stainless steel needle and poly(ethylene terephthalate) suture, for use in short term tissue approximation, including use in ophthalmic surgery.
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