Search Results

The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility. Acceptable method of sterilization is moist heat sterilization where the temperature is below 137℃ (273°F). The pouch may be re-used up to 30 times in dental practices and approved for 90 days storage.

The device is a re-usable sterilization pouch designed to The device the sterilization process and allow a simple method of packaging devices to maintain sterility.

This document is a 510(k) premarket notification approval letter for a Re-Useable Sterilization Pouch. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter primarily states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Ask a specific question about this device