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Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

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This FDA letter is a 510(k) clearance for the Autokeeper® Safety Pen Needle. It primarily addresses regulatory compliance and substantial equivalence to a predicate device. It does not contain a detailed study report or acceptance criteria for device performance as would be found in a clinical study or detailed engineering report.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from the provided text. This document is a regulatory approval letter, not a scientific study report.

To provide the requested information, a different document, such as a summary of safety and effectiveness data or a clinical study report, would be necessary.

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