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    K Number
    K080412
    Device Name
    ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
    Manufacturer
    SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2008-09-04

    (202 days)

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

    SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.
    Device Description
    Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is a synthetic absorbable suture based on Polyglycolic acid. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) coated with polycaprolactone and calcium stearate, has been found to be inert, non-antigenic and nonpyrogenic. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) are available dyed (violet) and undyed. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) complies with the requirements of USP and EP.
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