(122 days)
This is intended to enclose medical devices that are to be sterilized in a health care facility. The tray is intended to allow steam to penetrate to the enclosed medical devices.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Dental Sterilization Tray/Cassette". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily addresses the regulatory classification and premarket notification status of the device, confirming its substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given text.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).