5110(k)s – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 19 Jan 2011 17:54:56 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png 5110(k)s – Eisner Safety Consultants https://eisnersafety.com 32 32 FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s) https://eisnersafety.com/2011/01/19/fda-515-prog-initiative-webpage-reclassifed-preamen-class-iii-510ks/?utm_source=rss&utm_medium=rss&utm_campaign=fda-515-prog-initiative-webpage-reclassifed-preamen-class-iii-510ks Wed, 19 Jan 2011 17:54:56 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=1988 The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s.  Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.

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