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The extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister is intended to be used in conjunction with extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) Systems, adding to the original canister selections.

The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudates, infectious materials, and tissue debris from the wound bed. The extriCARE® 3600 Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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This document is a 510(k) clearance letter from the FDA for the extriCARE® 3600 Negative Pressure Wound Therapy 1000cc canister. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily covers:

• The FDA's determination of substantial equivalence.
• Regulatory requirements and guidelines for the manufacturer.
• The indications for use of the device.

Therefore, I cannot provide the requested information about acceptance criteria and study details from this document.

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