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127![510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following informiation provides sufficient detail to understand the basis for a determination of substantial equivalence. 1. Submitter Name 510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following informiation provides sufficient detail to understand the basis for a determination of substantial equivalence. 1. Submitter Name](https://www.pdfsearch.io/img/cd3986828ea3eb73ff0c7d8256055a48.jpg) | Add to Reading ListSource URL: www.accessdata.fda.govLanguage: English - Date: 2013-11-14 08:33:10
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