510(k) Review Page 1 THIS FORM REPLACES THE “SUBSTANTIAL EQUIVALENCE DECISION MAKING DOCUMENTATION” FOR EXEMPT DETERMINATIONS. ____________________________________________ Date:

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		510(k) Review Page 1 THIS FORM REPLACES THE “SUBSTANTIAL EQUIVALENCE DECISION MAKING DOCUMENTATION” FOR EXEMPT DETERMINATIONS. ____________________________________________ Date: Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 16,45 KB Share Document on Facebook