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Polyglytone*6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic Surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.

This document is a 510(k) summary for a synthetic absorbable suture. It outlines the device description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, or any study details that would allow a description of how the device meets acceptance criteria.

The information provided only demonstrates that the device's substantial equivalence determination was based on:

• A detailed device description.
• Performance testing (details not provided).
• Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, U.S.P. - Absorbable Surgical Sutures).
• Guidance from the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA".

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because those details are not present in the provided text.

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