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Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.

Deknatel® Deklene® Maxx™ Polypropylene Suture is a nonabsorbable, sterile surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is available dyed (blue) or undyed (colorless).

Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) except for suture sizes 7-0 and 8-0 which differ from USP in diameter only.

Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is available in USP sizes 8-0 through 0. The suture is provided in a variety of lengths, with and without 300 or 400 series stainless steel needles, with and without PTFE felt pledgets, and may be supplied in a variety of cut lengths. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.

The provided text is a 510(k) summary for a medical device (surgical suture) and does not contain information about the acceptance criteria or a study proving that an AI device meets acceptance criteria. The document explicitly states: "No clinical trials were conducted."

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