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The KSEA Endomat® LC pump provide suction during Genral and Urological examination and procedures.

The Karl Storz Endomat® LC Pump is a suction pump device which is use to provide suction during General and Urological examination / procedures.

I apologize, but the provided text from the FDA 510(k) Pre-Market Notification does not contain information related to the acceptance criteria, study details, or performance of the Endomat® LC Pump model Number 20 3303 20.

The document primarily focuses on:

• The FDA's decision regarding substantial equivalence to a predicate device.
• Regulatory information and compliance requirements for the device.
• The intended use/indications for use of the device: "The KSEA Endomat® LC Pump provides suction during General and Urological examination and procedures."
• A brief description of the device as a "suction pump device which is use to provide suction during General and Urological examination / procedures."

It explicitly states, "The minor differences between the Karl Storz Endomat® LC Suction Pump and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This suggests that the substantial equivalence was based on similarities to existing devices, and a specific clinical performance study with acceptance criteria, as one might find for a novel or significantly different device, is not detailed here.

Therefore, I cannot provide the requested table and study details.

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