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Re: Dr. Mugs post# 47130

Saturday, 09/10/2011 12:27:36 AM

Saturday, September 10, 2011 12:27:36 AM

Post# of 59551
Dr mugs, you clearly requested a FDA link. As far as the letters to IMGG are concerned, the FDA does state that another 510k application can be made. I would recommend more research on the "least burdensome provision on the FDA site, and yes, it applies to both PMA and 510k's, nice try tho!