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...System Processor (SS1), including the Sterilant 20, which is a liquid chemical sterilizer used to clean instruments such as endoscopes and bronchoscopes, FDA deemed the products adulterated for failing to have a PMA or IDE.
The agency also deemed the device misbranded because Steris did not notify the agency of its intent to introduce the device into commercial distribution.
The Steris System 1 Processor and Sterilant 20 were cleared in 1989 for marketing under a 510(k), according to the letter. However, the documents FDA collected revealed that there had been...
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