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510(k) Data Aggregation

    K Number
    K032586
    Date Cleared
    2003-11-17

    (87 days)

    Product Code
    Regulation Number
    878.4493
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    CAPROSYN ABSORBABLE SUTURE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Caprosyn* synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery.

    Device Description

    Absorbable poly(glycolide/L-lactide) surgical suture

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The documents are a brief summary of safety and effectiveness for a surgical suture and an FDA clearance letter for the same device. Therefore, I cannot provide the requested information.

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